Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Phase I, Open-Label, Dose Finding Study of Calaspargase Pegol-Mnkl in Combination With Cobimetinib in Locally-Advanced or Metastatic Pancreatic Cancer
This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of calaspargase pegol-mknl in combination with cobimetinib. SECONDARY OBJECTIVES: I. To assess the safety of calaspargase pegol-mknl in combination with cobimetinib. II. To assess preliminary response to treatment with calaspargase pegol-mknl and cobimetinib. III. To monitor levels of plasma asparaginase. EXPLORATORY OBJECTIVE: I. To evaluate therapy induced changes in the tumor and tumor ecosystem. OUTLINE: This is a dose-escalation study. Patients receive calaspargase pegol-mknl intravenously (IV) over 1 hour on day 1 and cobimetinib orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy 14 days prior to starting therapy and on day 14 of cycle 2. After completion of study intervention, patients are followed up at 3 and 6 months. ;
| 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 | |
| Recruiting |
NCT04132505 -
Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer
|
Phase 1 | |
| 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 |