Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Verastem, Inc.
Study ID
NCT05669482
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • KRAS Activating Mutation
  • Malignant Neoplasm of Pancreas
  • Metastatic Cancer
  • Neoplasms Pancreatic
  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 22, 2023
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
    To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
  • Experimental: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
    To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients

Primary Outcome Measure

Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel [ Time Frame: 28 days ]

Locations (12)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Cancer CenterAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York Presbyterian/Weill-Cornell Medical CenterNew YorkNew York10021-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in San Francisco, CA

By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Chicago· Chicago, ILDana Farber Cancer Institute· Boston, MAUniversity of Michigan Cancer Center· Ann Arbor, MIWashington University School of Medicine· St Louis, MOLaura & Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NY

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