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



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2015
End Date:December 2017
Contact:Laurie Lobue, RN
Email:llobue@verastem.com
Phone:781-292-4247

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A Phase 1 Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Subjects With Advanced Cancer

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.

The study is comprised of 2 sequential parts: Part A (Dose Escalation of VS-4718) in
subjects with advanced cancer and Part B (Expansion) in subjects with untreated advanced
pancreatic cancer.

Up to 60 evaluable subjects (i.e., subjects who complete at least 1 cycle (28 days) of
therapy) will be enrolled, assuming that:

1. Part A: The maximum sample size will be 6 subjects up to 4 dose levels (exclusive of
replacement subjects). However, additional subjects may be added if exploration of
intermediate dose level(s) of VS 4718 is warranted. The starting dose of VS-4718 will
be 200mg BID.

2. Part B: Up to 36 additional subjects may be enrolled at the RP2D. These subjects will
be randomized at a 1:1 ratio to 1 of 2 treatment cohorts:

- Cohort 1: IV treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes
on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8,
and 15) and oral VS 4718 BID continuously starting on Day 1 of Cycle 1

- Cohort 2: IV treatment for the first 2 cycles, followed by IV treatment and oral
VS-4718 BID continuously starting on Day 1 of Cycle 3

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
We found this trial at
5
sites
Gettysburg, Pennsylvania 17325
Phone: 717-334-4033
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Cleveland, Ohio 44106
Phone: 216-844-3951
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Cleveland, OH
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Detroit, Michigan 48201
Phone: 313-576-9717
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Detroit, MI
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New York, New York 10065
Phone: 646-888-3789
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New York, NY
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St Louis, Missouri 63108
Phone: 314-747-6268
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St Louis, MO
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