Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor's decision to deprioritize the program.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VS-4718 | Experimental | Oral VS-4718 administered BID (QD during first cohort) during a 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS-4718 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of VS-4718 in subjects with metastatic non-hematologic malignancies | Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety monitoring committee will review safety information. | Expected average of 12 weeks from start of treatment to end of treatment |
| Establish the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of VS-4718 in subjects with metastatic non-hematologic malignancies | The RP2D will be determined based on the maximum tolerated dose (MTD) of VS-4718 as determined by number of participants with dose limiting toxicities related to VS-4718. Observations related to pharmacokinetics, pharmacodynamics, and any VS-4718 related toxicities may be included in the rationale supporting the RP2D and will not exceed the MTD. | From start of treatment to end of cycle 1 (4 week cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of VS-4718 | Response rate and progression-free survival as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 | Every 8 weeks to end of treatment, expected average of 16 weeks |
| Evaluate duration of response to VS-4718 compared with duration of response to prior therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hagop Youssoufian, MD | Verastem, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C559284 | PND 1186 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Expected average of 16 weeks from start of treatment to end of treatment |
| Assess the pharmacokinetics of VS-4718 | PK (pharmacokinetics) parameters, including but not limited to clearance, plasma concentration, AUC (Area Under Curve, 0-24 and 0-t), Cmax, Tmax, and T1/2 | Time points on Day 1, 2, 8, 15, 16, and 29 |
| Evaluate biomarkers of VS-4718 activity | Pre and post dose biomarker analysis in serum and tumor samples to identify possible prognostic factors to VS-4718 response | Day 1 and Day 15 of treatment |
| Examine if the tumor expression status of pFAK and other plasma biomarkers correlates with response to VS-4718 therapy | Tumor expression status (pFAK, cancer stem cells, CSC, and other biomarkers) compared with response to VS-4718, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 | From start of treatment to end of treatment, an expected average of 16 weeks |
| Los Angeles |
| California |
| 90048 |
| United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Washington University School of Medicine, Division of Oncology | St Louis | Missouri | 63110 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |