Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects
Stopped early · Phase 1
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT02651727
- Run by
- Verastem, Inc.
- People needed
- 13
- Starts
- 2015-09-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2017-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
- Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
Full record on ClinicalTrials.gov
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