PRIMARY OBJECTIVE:
I. Assess the pharmacodynamic (PD) feasibility of detecting a measurable change in tumor biology at post-treatment from baseline (i.e., before the 10-day treatment window) for all feasibility-evaluable participants.
SECONDARY OBJECTIVES:
I. Assess preliminary safety and tolerability of the proposed study agent(s) in each study arm.
II. Assess the PD feasibility of detecting a measurable change in tumor biology at post-treatment from baseline (i.e., before the 10-day treatment window) among participants in an assigned study arm.
EXPLORATORY OBJECTIVES:
I. Identify predictive biomarkers of sensitivity to assigned study agent(s). II. Identify emerging mechanism(s) of resistance to assigned study agent(s). III. Determine cellular and molecular changes in pancreatic tumor cells exposed to assigned study agent(s).
IV. Identify tumor markers suggestive of combinatorial therapy that could overcome resistance to therapy.
OUTLINE: Patients are assigned to 1 of 4 arms.
ARM I: Patients receive cobimetinib orally (PO) once daily (QD) on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient’s disease.
ARM II: Patients receive olaparib PO twice daily (BID) on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient’s disease.
ARM III: Patients receive temuterkib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient’s disease.
ARM IV: Patients receive onvansertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient’s disease.
After completion of study treatment, patients are followed up for 30 days.
Source: View full study details on ClinicalTrials.gov
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