Status:
TERMINATED
Phase I Dose Escalation Study of VS-4718 in Subjects With Metastatic Non-Hematologic Malignancies
Lead Sponsor:
Verastem, Inc.
Conditions:
Non Hematologic Cancers
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 compri...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histopathologically confirmed diagnosis of a metastatic non-hematologic malignancy.
- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
- Adequate renal function
- Adequate hepatic function (total bilirubin ≤ 1.5x ULN (upper limit of normal) for the institution; AST \[aspartate transaminase\] and ALT \[alanine transaminase\] ≤ 3x ULN, or ≤ 5x ULN if due to liver involvement by tumor).
- Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100 x10 9 cells/L; absolute neutrophil count ≥ 1.5x10 9 cells/L
- Corrected QT interval (QTc) \< 470 ms
- Subjects must have at least one tumor lesion that is suitable for repeat biopsy, and must agree to two tumor biopsies (pre- and post- treatment).
- Willing and able to participate in the trial and comply with all trial requirements.
Exclusion
- Gastrointestinal (GI) condition which 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 12 months.
- Known history of stroke or cerebrovascular accident within 6 months.
- Subjects being actively treated for a secondary malignancy.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01849744
Start Date
June 1 2013
End Date
June 1 2017
Last Update
July 28 2017
Active Locations (5)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Washington University School of Medicine, Division of Oncology
St Louis, Missouri, United States, 63110