Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

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