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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Non-small Cell Lung

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514864

CA180-385

2011-003128-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:.

  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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups

Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)

Experimental group

Description:

Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred

Treatment:

Drug: Dasatinib

Dasatinib, 140 mg (NSCLC With DDR2 Mutation)

Experimental group

Description:

Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred

Treatment:

Drug: Dasatinib