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

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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.


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
Barretos, Sao Paulo 14784
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Tampa, FL
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