Trials / Active Not Recruiting
Active Not RecruitingNCT05669482
Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer
A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Verastem, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.
Detailed description
This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients previously untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Conditions
- KRAS Activating Mutation
- Metastatic Cancer
- Pancreas Cancer
- Neoplasms Pancreatic
- Malignant Neoplasm of Pancreas
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel | The RP2D of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel determined in Part A will be used in Part B dose expansion. |
Timeline
- Start date
- 2023-03-22
- Primary completion
- 2026-08-31
- Completion
- 2027-08-31
- First posted
- 2022-12-30
- Last updated
- 2025-09-02
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05669482. Inclusion in this directory is not an endorsement.