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Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non-small Cell Lung

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Trial Information

Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

Inclusion Criteria:

- Diagnosis of advanced malignancy, Non-Small Cell Lung Cancer (NSCLC) only during
stage 1 of accrual

- Non-synonymous mutation of B-RAF or DDR2, defined as follows:

- NSCLC with inactivating B-RAF mutation

- NSCLC of squamous type with DDR2 mutation

- Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation,
or NSCLC or melanoma having a B-RAF mutation which is not functionally

- At least one target lesion per Response Evaluation Criteria in Solid Tumors (RECIST)
1.1 criteria on baseline staging evaluation

- Disease progression after ≥ 1 prior treatment regimen *Exception: Subjects with NSCLC
of squamous type may be enrolled in first line, no prior treatment is required

Exclusion Criteria:

- Pleural or pericardial effusion Grade > 1

- QTcF > 470 msec (Grade ≥ 2) or diagnosed congenital long QT syndrome

- Absolute granulocyte count < 1,500/mm3

- Hemoglobin < 10 g/dL

- Platelet count < 75,000/mm3

- Serum calcium < institutional Lower limit of normal (LLN)

- Hypokalemia, hypophosphatemia or hypomagnesemia Grade > 1, despite supplementation

- Creatinine > 3 x institutional Upper Limit of Normal (ULN)

- Total bilirubin > 1.5 x ULN

- Alanine transaminase (ALT) > 3 x ULN

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate by stratum is defined as the proportion of response-evaluable subjects with best tumor response of Partial Response (PR) or Complete Response (CR)

Outcome Time Frame:

Month 24

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

July 2017

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung



Memorial Sloan Kettering Cancer Center New York, New York  10021
H. Lee Moffitt Cancer & Research Institute Tampa, Florida  33612