Pancreatic Cancer Clinical Trial
Official title:
A Phase 1 Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Subjects With Advanced Cancer
Verified date | January 2017 |
Source | Verastem, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gettysburg Cancer Center | Gettysburg | Pennsylvania |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Verastem, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicities (DLTs) | Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of VS-4718 in combination with gemcitabine and nab-paclitaxel | 6 months | |
Secondary | Progression Free Survival | From the date of first treatment to the date of progression including death from any cause, expected average at least 5 months | ||
Secondary | Response rate (RR) | RR is measured as the best overall response using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. | Every 8 weeks from baseline through the end of treatment, an expected average of 5 months] | |
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Clearance | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle | ||
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Plasma concentration | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle | ||
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Area under the plasma concentration versus time curve (AUC) | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle | ||
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Maximum observed plasma concentration (Cmax) | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle | ||
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Time to reach maximum observed concentration (Tmax) | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle | ||
Secondary | Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Half life (T1/2) | Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle |
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