Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to determine a recommended Phase 2 dose (RP2D) for further development of this combination in subjects with untreated advanced pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verastem, Inc.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Histologically or cytologically confirmed diagnosis of an advanced nonhematological malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not surgically resectable

• Eligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in 28-day cycles as standard therapy

• Evaluable or measurable disease, as assessed by RECIST v1.1

• ECOG performance status of ≤ 1

• Adequate renal function (creatinine ≤ 1.5×ULN [upper limit of normal]) or glomerular filtration rate of ≥ 60 mL/min

• Adequate hepatic function (total bilirubin ≤ 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ≤ 2.5×ULN, or ≤ 5×ULN if due to liver involvement by tumor; albumin ≥ 3 g/dL)

• Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100×109 cells/L; absolute neutrophil count [ANC] ≥ 1.5×109 cells/L without the use of hematopoietic growth factors)

• Corrected QT interval (QTc) < 470 ms

• Willing and able to participate in the trial and comply with all trial requirements

Exclusion Criteria:

• Gastrointestinal (GI) condition that could interfere with the swallowing or absorption of study medication

• Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).

• History of upper gastrointestinal bleeding, ulceration, or perforation within 6 months prior to the first dose of protocol therapy

• Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of protocol therapy.

• Part B only: Prior therapy (including investigational agents) for pancreatic cancer

• Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy

• Active treatment for a secondary malignancy