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A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey, United States, 07920 Contact: Raajit Rampal, MD,PhD    646-608-3746       Memorial Sloan Kettering Monmouth Middletown, New Jersey, United States, 07748 Contact: Raajit Rampal, MD, PhD    646-608-3746       Memorial Sloan Kettering Bergen Montvale, New Jersey, United States, 07645 Contact: Raajit Rampal, MD, PhD    646-608-3746       Memorial Sloan Kettering Suffolk – Commack Commack, New York, United States, 11725 Contact: Raajit Rampa, MD, PhD    646-608-3746       Memorial Sloan Kettering Westchester Harrison, New York, United States, 10604 Contact: Raajit Rampal, MD, PhD    646-608-3746       Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065 Contact: Raajit Rampal, MD, PhD    646-608-3746       Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale, New York, United States, 11553 Contact: Raajit Rampal, MD, PhD    646-608-3746      

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 8, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Weight Discrimination and Poor Cardiovascular Health

Discrimination is a critical social determinant of health that underlies poor health outcomes. One common but understudied form of discrimination is weight discrimination. Weight discrimination is the behavioral manifestation of weight stigma-the social devaluation of people with excess body weight. Findings suggest that the stress produced by weight discrimination prompts weight gain, creating a vicious cycle between weight discrimination and obesity. Further, there is now well-documented evidence that experiencing weight discrimination is associated with increased risk for cardiovascular disease. Little is known, however, about mechanisms explaining the link between weight discrimination and poor cardiovascular health. Using a rigorous experimental approach, this project will identify mechanisms through which weight discrimination harms health. Findings will facilitate the long-term goal of this research: interventions to decrease the negative health consequences of weight discrimination.
As a step toward this goal, this project proposes to conduct an experiment in which a diverse sample of adults with obesity will be randomly assigned to experience (vs. not experience) weight discrimination in a controlled experimental setting. Drawing on previous research and the investigators’ pilot data, the interpersonal context chosen for the study simulates situations in which people with obesity commonly experience weight discrimination in their daily lives (e.g., employment settings).
The following aims will be tested: (1) Identify early-stage cognitive, affective, behavioral, and physiological mechanisms activated by experimentally manipulated weight discrimination; (2) Identify psychological variables (e.g., internalized weight bias) that moderate effects of weight discrimination; and (3) Identify demographic characteristics (e.g., gender, race) that moderate effects of weight discrimination. Exposure to weight discrimination (vs. control) is hypothesized to result in elevated responses on early-stage mechanisms that culminate in poor cardiovascular health (e.g., impaired self-regulation, higher negative emotion, more social withdrawal and comfort eating, increased cortisol secretion). This research will identify novel and highly modifiable targets for interventions designed to reduce the negative health effects of weight discrimination. In testing moderator variables, this work will identify individuals who display vulnerability vs. resilience to the harmful effects of discrimination. Information about moderators will thus help future intervention efforts target those individuals most likely to benefit from intervention. Given the high prevalence of obesity and the millions of Americans affected by weight discrimination, this research will address a crucial public health issue.
If you are interested in enrolling the study, you can follow the link in the advertisement to an online screening survey where eligibility will be assessed. If eligible, you will be invited to enroll in the study, which will involve two parts: a pre-session baseline survey and an experimental session that will take place in the lab. The baseline survey will be completed online and assess individual difference variables/psychological variables and demographic characteristics. The in-person lab visit will take place on campus about one week after completion of the baseline survey. The study manipulation (i.e., intervention) will be delivered during the lab visit. Primary outcome variables will be assessed during the lab visit, after delivery of the intervention.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

Experimental: Sequence A
Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.
Drug: Semaglutide B, 1.34 mg/mL
Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Drug: Semaglutide B, 0.68 mg/mL
Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients

Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not have the limitation of traditional IP regimen of post-operative adhesions. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 millimeters; moreover, hyperthermia can potentiate its antineoplastic effects.
In recent times, morbidity and mortality associated with HIPEC has drastically improved. One large retrospective review of 694 patients, treated between 2005 and 2011, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQUIP) database, demonstrated a complication rate of 33% and 30-day mortality of 2.3%, both rates consistent with outcomes for other major complex abdominal operations.
Recently, a Phase I dose escalation study to evaluate maximum tolerated dose (MTD) of HIPEC administration of cisplatin in recurrent epithelial ovarian cancer (EOC) patients was published. The MTD of cisplatin was 100 milligrams per meter squared (mg/m2) with no mortality or safety concerns. While the trial had only 12 patients, all were able to receive post-operative IV chemotherapy, with all patients completing at least five cycles.
In protocol Gynecologic Oncology Group (GOG)-0172, intraperitoneal cisplatin and paclitaxel, plus intravenous paclitaxel, demonstrated the longest median survival reported in optimally debulked stage III ovarian cancer. Currently, the GOG is studying variations of the intraperitoneal (IP) regimen to preserve the survival advantage, but make it tolerable for patients to receive 6 cycles without discontinuing therapy due to distress and toxicity. The importance of developing an acceptable GOG-0172 alternative is emphasized by the recent National Cancer Institute (NCI) Clinical Announcement recognizing the superiority of intraperitoneal chemotherapy in the optimal disease setting.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab in patients with selected advanced gynecologic and genitourinary malignancies and to identify tumor types for further evaluation.
In Stage 1, subjects will be enrolled into 1 of 5 tumor-specific, parallel cohorts (n = 10 each):

Platinum-resistant high-grade serous ovarian cancer (HGSOC)
Chemotherapy relapsed or refractory clear cell ovarian, endometrial, or peritoneal cancer
Immune-checkpoint-inhibitor-refractory microsatellite stable (MSS) endometrial cancer (EC)
Previously treated recurrent or metastatic cervical cancer
High-risk metastatic castration-resistant prostate cancer (mCRPC)

Within each tumor-specific cohort in Stage 1, a primary endpoint of ORR at 12 weeks, based on investigator review, will be used to determine cohort expansion into Stage 2. Each Stage 1 cohort that achieves an ORR of ≥ 20% (at least 2 out of 10 subjects with an objective response) will enroll up to an additional 20 subjects in Stage 2. Cohorts with an ORR of less than 20% will discontinue enrollment. However, additional factors will be considered in determining an expansion into Stage 2 (eg, enrollment rate, complete versus partial response, and DOR).

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study

Clinical Investigation
All participants will undergo GFR (Iohexol Inj 300 MG/ML), ERPF (Aminohippurate Sodium Inj 20%) in addition to renal BOLD and ASL MRI.
Drug: Aminohippurate Sodium Inj 20%
Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
Other Names:

Sodium 4-amino hippurate (PAH) inj 20% 2g/10mL
Para-aminohippurate
Aminohippuric acid

Drug: Iohexol Inj 300 MG/ML
Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
Other Name: omnipaque 300
Procedure: Renal Biopsy
Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.
Other Name: Kidney Biopsy

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Novo Nordisk Investigational Site

Concord, California, United States, 94553

Novo Nordisk Investigational Site

Escondido, California, United States, 92025

Novo Nordisk Investigational Site

Fullerton, California, United States, 92835

Novo Nordisk Investigational Site

Huntington Beach, California, United States, 92648

Novo Nordisk Investigational Site

Lincoln, California, United States, 95648

Novo Nordisk Investigational Site

Lincoln, California, United States, 95648

Novo Nordisk Investigational Site

Los Angeles, California, United States, 90057

Novo Nordisk Investigational Site

Palm Springs, California, United States, 92262

Novo Nordisk Investigational Site

Walnut Creek, California, United States, 94598

Novo Nordisk Investigational Site

Golden, Colorado, United States, 80401

Novo Nordisk Investigational Site

Clearwater, Florida, United States, 33765

Novo Nordisk Investigational Site

Fleming Island, Florida, United States, 32003

Novo Nordisk Investigational Site

Jacksonville, Florida, United States, 32216

Novo Nordisk Investigational Site

Ocala, Florida, United States, 34470

Novo Nordisk Investigational Site

Orlando, Florida, United States, 32804

Novo Nordisk Investigational Site

Roswell, Georgia, United States, 30076

Novo Nordisk Investigational Site

Roswell, Georgia, United States, 30076

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States, 96814

Novo Nordisk Investigational Site

Chicago, Illinois, United States, 60607

Novo Nordisk Investigational Site

West Des Moines, Iowa, United States, 50265

Novo Nordisk Investigational Site

Topeka, Kansas, United States, 66606-2806

Novo Nordisk Investigational Site

Louisville, Kentucky, United States, 40213

Novo Nordisk Investigational Site

Baton Rouge, Louisiana, United States, 70808

Novo Nordisk Investigational Site

Buckley, Michigan, United States, 49620

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States, 55416

Novo Nordisk Investigational Site

Saint Peters, Missouri, United States, 63303

Novo Nordisk Investigational Site

Butte, Montana, United States, 59701

Novo Nordisk Investigational Site

Albany, New York, United States, 12203

Novo Nordisk Investigational Site

West Seneca, New York, United States, 14224

Novo Nordisk Investigational Site

Westfield, New York, United States, 14787

Novo Nordisk Investigational Site

Greensboro, North Carolina, United States, 27408

Novo Nordisk Investigational Site

Simpsonville, South Carolina, United States, 29681-1538

Novo Nordisk Investigational Site

Simpsonville, South Carolina, United States, 29681-1538

Novo Nordisk Investigational Site

Kingsport, Tennessee, United States, 37660

Novo Nordisk Investigational Site

Kingsport, Tennessee, United States, 37660

Novo Nordisk Investigational Site

Amarillo, Texas, United States, 79106

Novo Nordisk Investigational Site

Austin, Texas, United States, 78731

Novo Nordisk Investigational Site

Austin, Texas, United States, 78749

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75230

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75231

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75390-9302

Novo Nordisk Investigational Site

Houston, Texas, United States, 77079

Novo Nordisk Investigational Site

Longview, Texas, United States, 75605

Novo Nordisk Investigational Site

Shavano Park, Texas, United States, 78231

Novo Nordisk Investigational Site

Shavano Park, Texas, United States, 78231

Novo Nordisk Investigational Site

Saint George, Utah, United States, 84790

Novo Nordisk Investigational Site

Richmond, Virginia, United States, 23294

Novo Nordisk Investigational Site

Winchester, Virginia, United States, 22601-3834

Novo Nordisk Investigational Site

Winchester, Virginia, United States, 22601

Novo Nordisk Investigational Site

Olympia, Washington, United States, 98502

Novo Nordisk Investigational Site

Graz, Austria, 8036

Novo Nordisk Investigational Site

Linz, Austria, 4021

Novo Nordisk Investigational Site

Wien, Austria, 1030

Novo Nordisk Investigational Site

Wien, Austria, 1090

Novo Nordisk Investigational Site

Wien, Austria, A 1190

Novo Nordisk Investigational Site

Calgary, Alberta, Canada, T2H 2G4

Novo Nordisk Investigational Site

Calgary, Alberta, Canada, T2V 4J2

Novo Nordisk Investigational Site

Victoria, British Columbia, Canada, V8V 4A1

Novo Nordisk Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7

Novo Nordisk Investigational Site

Brampton, Ontario, Canada, L6S 0C6

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada, M9R 4E1

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada, L8L 5G8

Novo Nordisk Investigational Site

London, Ontario, Canada, N5W 6A2

Novo Nordisk Investigational Site

Nepean, Ontario, Canada, K2J 0V2

Novo Nordisk Investigational Site

Toronto, Ontario, Canada, M6G 1M2

Novo Nordisk Investigational Site

Montreal, Quebec, Canada, H4N 2W2

Novo Nordisk Investigational Site

Montreal, Quebec, Canada, H4T 1Z9

Novo Nordisk Investigational Site

Bad Mergentheim, Germany, 97980

Novo Nordisk Investigational Site

Elsterwerda, Germany, 04910

Novo Nordisk Investigational Site

Essen, Germany, 45136

Novo Nordisk Investigational Site

Freiburg, Germany, 79106

Novo Nordisk Investigational Site

Hamburg, Germany, 22607

Novo Nordisk Investigational Site

Leipzig, Germany, 04107

Novo Nordisk Investigational Site

Münster, Germany, 48145

Novo Nordisk Investigational Site

Stuttgart, Germany, 70378

Novo Nordisk Investigational Site

Wangen, Germany, 88239

Novo Nordisk Investigational Site

Debrecen, Hajdu-Bihar, Hungary, 4032

Novo Nordisk Investigational Site

Budapest, Hungary, 1033

Novo Nordisk Investigational Site

Budapest, Hungary, 1042

Novo Nordisk Investigational Site

Budapest, Hungary, 1106

Novo Nordisk Investigational Site

Komárom, Hungary, 2900

Novo Nordisk Investigational Site

Szeged, Hungary, H-6725

Novo Nordisk Investigational Site

Szolnok, Hungary, 5004

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India, 380006

Novo Nordisk Investigational Site

Bangalore, Karnataka, India, 560054

Novo Nordisk Investigational Site

Kozhikode, Kerala, India, 673008

Novo Nordisk Investigational Site

Thiruvananthapuram, Kerala, India, 695031

Novo Nordisk Investigational Site

Kolhapur, Maharashtra, India, 416008

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India, 400008

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India, 400012

Novo Nordisk Investigational Site

Pune, Maharashtra, India, 411013

Novo Nordisk Investigational Site

Ansari Nagar, New Delhi, India, 110029

Novo Nordisk Investigational Site

Chandigarh, Punjab, India, 160012

Novo Nordisk Investigational Site

Jaipur, Rajasthan, India, 302004

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India, 600006

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India, 600086

Novo Nordisk Investigational Site

Hyderabad, Telengana, India, 500004

Novo Nordisk Investigational Site

Kolkata, West Bengal, India, 700054

Novo Nordisk Investigational Site

Nagpur, India, 440010

Novo Nordisk Investigational Site

New Delhi, India, 110001

Novo Nordisk Investigational Site

Galway, Connaght, Ireland, H91 YR71

Novo Nordisk Investigational Site

Dublin, Leinster, Ireland, D08 A978

Novo Nordisk Investigational Site

Dublin, Leinster, Ireland, DUBLIN 4

Novo Nordisk Investigational Site

Dublin, Leinster, Ireland, DUBLIN 7

Novo Nordisk Investigational Site

Aichi, Japan, 468-0009

Novo Nordisk Investigational Site

Chiba, Japan, 261-0004

Novo Nordisk Investigational Site

Osaka, Japan, 530-0001

Novo Nordisk Investigational Site

Osaka, Japan, 565-0871

Novo Nordisk Investigational Site

Osaka, Japan, 569-1045

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, Malaysia, 16150

Novo Nordisk Investigational Site

Cheras, Kuala Lumpur, Malaysia, 56000

Novo Nordisk Investigational Site

Sarawak, Miri, Malaysia, 98000

Novo Nordisk Investigational Site

Seri Manjung, Perak, Malaysia, 32040

Novo Nordisk Investigational Site

Kuching, Sarawak, Malaysia, 93586

Novo Nordisk Investigational Site

Ampang, Selangor, Selangor, Malaysia, 68000

Novo Nordisk Investigational Site

Sungai Buloh, Selangor, Malaysia, 47000

Novo Nordisk Investigational Site

Melaka, Malaysia, 75400

Novo Nordisk Investigational Site

Putrajaya, Malaysia, 62250

Novo Nordisk Investigational Site

Seremban, Malaysia, 70300

Novo Nordisk Investigational Site

Warszawa, Mazovian, Poland, 02-117

Novo Nordisk Investigational Site

Warszawa, Mazovian, Poland, 02-117

Novo Nordisk Investigational Site

Bialystok, Podlaskie, Poland, 15-281

Novo Nordisk Investigational Site

Bialystok, Podlaskie, Poland, 15-281

Novo Nordisk Investigational Site

Poznan, Wielkopolskie, Poland, 60-589

Novo Nordisk Investigational Site

Poznan, Wielkopolskie, Poland, 60-589

Novo Nordisk Investigational Site

Bialystok, Poland, 15-276

Novo Nordisk Investigational Site

Bygdoszcz, Poland, 85-796

Novo Nordisk Investigational Site

Bygdoszcz, Poland, 85-796

Novo Nordisk Investigational Site

Elblag, Poland, 82-300

Novo Nordisk Investigational Site

Gdansk, Poland, 80-952

Novo Nordisk Investigational Site

Katowice, Poland, 40-001

Novo Nordisk Investigational Site

Kraków, Poland, 30-721

Novo Nordisk Investigational Site

Kraków, Poland, 30-721

Novo Nordisk Investigational Site

Legnica, Poland, 59-220

Novo Nordisk Investigational Site

Lublin, Poland, 20-333

Novo Nordisk Investigational Site

Lublin, Poland, 20-333

Novo Nordisk Investigational Site

Warszawa, Poland, 00-416

Novo Nordisk Investigational Site

Ponce, Puerto Rico, 00716

Novo Nordisk Investigational Site

Bangkoknoi, Bangkok, Bangkok, Thailand, 10700

Novo Nordisk Investigational Site

Muang, Khon Kaen, Thailand, 40002

Novo Nordisk Investigational Site

Klong Luang, Pathumthani, Pathumthani, Thailand, 12120

Novo Nordisk Investigational Site

Bangkok, Thailand, 10330

Novo Nordisk Investigational Site

Bangkok, Thailand, 10400

Novo Nordisk Investigational Site

Addlestone, Surrey, United Kingdom, KT15 2BH

Novo Nordisk Investigational Site

Antrim, United Kingdom, BT42 2RL

Novo Nordisk Investigational Site

Blackpool, United Kingdom, FY3 7EN

Novo Nordisk Investigational Site

Bradford-on-Avon, United Kingdom, BA15 1DQ

Novo Nordisk Investigational Site

Bristol, United Kingdom, BS10 5NB

Novo Nordisk Investigational Site

Chippenham, United Kingdom, SN14 6GT

Novo Nordisk Investigational Site

Harrogate, North Yorkshire, United Kingdom, HG2 7SX

Novo Nordisk Investigational Site

Hounslow,, United Kingdom, TW5 9ER

Novo Nordisk Investigational Site

Leicester, United Kingdom, LE5 4PW

Novo Nordisk Investigational Site

Nantwich, United Kingdom, CW5 5NX

Novo Nordisk Investigational Site

Rotherham, United Kingdom, S651DA

Novo Nordisk Investigational Site

Sandbach, United Kingdom, CW11 1EQ

Novo Nordisk Investigational Site

Soham, United Kingdom, CB7 5JD

Novo Nordisk Investigational Site

Swansea, United Kingdom, SA2 8PP

Novo Nordisk Investigational Site

Taunton, United Kingdom, TA1 5DA

Novo Nordisk Investigational Site

Truro, United Kingdom, TR1 3LJ

Novo Nordisk Investigational Site

Wellingborough, United Kingdom, NN8 4RW

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Experimental: Dose Escalation of VIP236

Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer

Drug: VIP236

VIP236 is a small molecule drug conjugate (SMDC) consisting of an alpha v beta 3 (αVβ3) integrin binder linked to an optimized camptothecin (CPT) compound (VIP126), which is released by the enzyme neutrophil elastase (NE) in the tumor microenvironment (TME).

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 7, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases
Experimental: Pre-Surgery Nivolumab + Ipilimumab

Patients will be given one dose of Nivolumab (1mg/kg IV) and Ipilimumab (3mg/kg IV) prior to standard of care surgery for tumor resection.

Drug: Nivolumab

Nivolumab is a monoclonal antibody o PD-1 protein, which is normally express on the surface of activated T cells. The interaction of PD-1 with its ligand (PD-L1) on T cells decreases their cytotoxic activity, helping protect normal cells in the setting of chronic inflammation. Tumor cells can utilize mechanisms to evade T cell mediated cytotoxicity by expressing PD-L1 on their surface or on the surface of T cells. Nivo, by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, allows T cells to remain active.

Other Name: Opdivo

Drug: Ipilimumab

Ipilimumab is a recombinant, human antibody to CTLA-4.[18-20] CTLA-4 regulates T cell activation by binding with CD80 or CD86 with higher affinity than CD28, resulting in blockage of the co-stimulation signal and preventing further T cell activation. Blockade of CTLA-4 results in further T cell activation.

Other Name: Yervoy

Procedure: Standard of Care Craniotomy

Participants will undergo craniotomy for surgical resection of melanoma brain metastases.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 6, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
  • To quantify the change over time in PRO-CTCAE derived symptoms [ Time Frame: Baseline ]

    Outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following sale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.

  • To quantify the change over time in PRO-CTCAE derived symptoms [ Time Frame: Weekly for 12 weeks ]

    Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.

  • To quantify the change over time in PRO-CTCAE derived symptoms [ Time Frame: Month 1 following completion of chemotherapy ]

    Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.

  • To quantify the change over time in PRO-CTCAE derived symptoms [ Time Frame: Month 3 following completion of chemotherapy ]

    Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.

  • To quantify the change over time in PRO-CTCAE derived symptoms [ Time Frame: Month 6 following completion of chemotherapy ]

    Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.

  • Source: View full study details on ClinicalTrials.gov

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    February 5, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine