Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
Binimetinib Plus Hydroxychloroquine in KRAS Mutant Metastatic Pancreatic Cancer
This phase I trial studies the best dose of hydroxychloroquine when given together with binimetinib in treating patients with KRAS gene mutated pancreatic cancer that has spread to other places in the body (metastatic). Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hydroxychloroquine may prevent autophagy, a normal process in which a cell destroys proteins and other substances which may lead to cell death. Autophagy may prevent normal cells from developing into tumor cells, but it may also protect tumor cells by destroying anticancer drugs or substances taken up by them. Giving hydroxychloroquine together with binimetinib may work better in treating patients with pancreatic cancer compared to binimetinib alone.
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of hydroxychloroquine (HCQ) when combined with a fixed dose of binimetinib. SECONDARY OBJECTIVES: I. To determine the response rate among a pilot cohort of pancreatic cancer patients. II. To determine the safety and toxicity profile of the combination of binimetinib and HCQ. III. To determine the ability of the combination to halt tumor growth as measured by progression free survival. IV. To assess the overall survival of patients treated on this regimen. EXPLORATORY OBJECTIVES: I. To compare the efficacy of treatment to somatic gene mutation profile as acquired by standard of care testing. II. To assess pre- and post- treatment tissue to determine if markers of autophagy correlate with response to treatment. III. To assess the effect of this binimetinib/HCQ treatment on changes in muscle and fat mass as analyzed by computed tomography (CT) scan (as standard of care treatment). OUTLINE: This is a dose-escalation study of hydroxychloroquine. Patients receive binimetinib orally (PO) twice daily (BID) and hydroxychloroquine PO BID on days 1-14. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 30 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01964287 -
First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
|
Phase 1/Phase 2 | |
| Completed |
NCT02826486 -
Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)
|
Phase 2 | |
| Active, not recruiting |
NCT04524702 -
Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02890355 -
FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04652206 -
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
|
Phase 1/Phase 2 | |
| Completed |
NCT00998322 -
A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma
|
Phase 2 | |
| 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 | |
| Completed |
NCT02562898 -
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05642962 -
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
|
Phase 1/Phase 2 | |
| Completed |
NCT01896869 -
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03337087 -
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02677038 -
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02985125 -
LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05383352 -
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
|
Phase 1 | |
| Completed |
NCT03943667 -
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
|
Phase 3 | |
| Completed |
NCT02436668 -
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
|
Phase 3 | |
| Completed |
NCT01360853 -
Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
|
Phase 3 | |
| Completed |
NCT01124786 -
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
|
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 |