Metastatic Cancer Clinical Trial
— RAMP205Official title:
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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Verastem, Inc. |
United States,
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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