Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Status: | Terminated |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2012 |
End Date: | July 2014 |
Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
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.
discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to
dasatinib.
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:
- NSCLC with inactivating B-RAF mutation
- NSCLC with discoidin domain receptor 2 (DDR2) mutation
- 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
- 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
We found this trial at
3
sites
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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