Status:
TERMINATED
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Carcinoma, Non-small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Inclusion Criteria
- Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual.
- Nonsynonymous mutation of B-RAF or DDR2, defined as follows:.
- i) NSCLC with inactivating B-RAF mutation.
- ii) NSCLC with discoidin domain receptor 2 (DDR2) mutation.
- iii) Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized.
- At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation.
- Disease progression after ≥ 1 prior treatment regimen.
- Exclusion Criteria
- Pleural or pericardial effusion, Grade \>1.
- QTcF \>470 msec (Grade ≥2) or diagnosed congenital long QT syndrome.
- Absolute granulocyte count \<1500/mm\^3.
- Hemoglobin level \<10 g/dL.
- Platelet count \< 75,000/mm\^3.
- Serum calcium level \<institutional lower limit of normal.
- Hypokalemia, hypophosphatemia, or hypomagnesemia, Grade \>1, despite supplementation.
- Creatinine \>3\*institutional upper limit of normal (ULN).
- Total bilirubin level \>1.5\*ULN.
- Alanine transaminase level \>3\*ULN.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
May 31 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01514864
Start Date
May 31 2012
End Date
July 23 2014
Last Update
December 19 2023
Active Locations (24)
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1
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
4
Local Institution
Barretos, São Paulo, Brazil, 14784-400