Stage IV Pancreatic Cancer AJCC v8 Clinical Trial
Official title:
A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma
This early phase I trial aims to determine how cobimetinib, olaparib, LY3214996, or onvansertib works in patients with pancreatic cancer. Validation of cobimetinib, or olaparib, LY3214996, and onvansertib molecular targets will be explored by comparing pre-treatment biopsies with post-treatment specimens. This knowledge will help design future biomarker driven trials to determine whether giving cobimetinib, or olaparib, LY3214996, or onvansertib will work better than standard treatments in patients with pancreatic cancer.
PRIMARY OBJECTIVE: I. Independently assess the pharmacodynamic (PD) feasibility of detecting a measurable change in tumor biology at post-treatment from baseline (i.e., before the study treatment window) for all feasibility-evaluable participants in each study arm. SECONDARY OBJECTIVES: I. Assess preliminary safety and tolerability of the proposed study agent(s) in each 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 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 II: 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 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. ARM V: Patients receive azenosertib 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03925428 -
Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04524702 -
Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04158635 -
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT04132505 -
Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04514497 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT04673448 -
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06206876 -
FL118 for Treating Patients With Advanced Pancreatic Ductal Adenocarcinoma
|
Phase 1 | |
Recruiting |
NCT05053971 -
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
Terminated |
NCT04390243 -
Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation
|
Phase 2 | |
Terminated |
NCT03723915 -
Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT03291938 -
IACS-010759 in Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT04539808 -
NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01585805 -
Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT06454383 -
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT05038254 -
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
|
N/A | |
Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT02983578 -
Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer
|
Phase 2 | |
Completed |
NCT04067960 -
Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer
|
Early Phase 1 | |
Not yet recruiting |
NCT06381154 -
Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04115163 -
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
|
Phase 2 |