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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05669482
Other study ID # VS-6766-205
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 22, 2023
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Verastem, Inc.
Contact Verastem Call Center
Phone 1 781 292 4204
Email clinicaltrials@verastem.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female subjects = 18 years of age - Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma. - An Eastern Cooperative Group (ECOG) performance status = 1 - Measurable disease according to RECIST 1.1 - Adequate organ function - Adequate cardiac function - Agreement to use highly effective method of contraceptive Exclusion Criteria: - Patients with pancreatic neuroendocrine tumors - Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma - Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAK - History of prior malignancy, with the exception of curatively treated malignancies - Major surgery within 4 weeks (excluding placement of vascular access) - Concurrent heart disease or severe obstructive pulmonary disease - Concurrent ocular disorders - Active skin disorder that has required systemic therapy within the past 1 year - Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome - Known SARS-Cov2 infection =28 days prior to first dose of study therapy

Study Design


Intervention

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.

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York Presbyterian/Weill-Cornell Medical Center New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Huntsman Cancer Institute Salt Lake City Utah
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Fred Hutchinson Cancer Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Verastem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel Assessment of Dose-limiting toxicities (DLTs) 28 days
Primary To determine the efficacy of the RP2D identified in Part A Confirmed overall response rate (ORR) (partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) 6 months
Secondary Duration of Response (DOR) Time of first response to PD as assessed per RECIST 1.1 24 months
Secondary Disease Control Rate (DCR) CR + PR + SD as assessed per RECIST 1.1 24 months
Secondary Progression Free Survival (PFS) From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause 24 months
Secondary Overall Survival (OS) From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause Up to 5 years
Secondary Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Tmax Time to Maximum concentration (Tmax) 10 weeks
Secondary Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, AUC Area under plasma Concentration (AUC) 0 to t 10 Weeks
Secondary Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Half-life concentration Half-life (T1/2) 10 weeks
Secondary Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs) Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale 24 months
Secondary Number of abnormal laboratory values Count of abnormal laboratory values by grade 24 months
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