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

Stopped early · Phase 2

Conditions studied: Carcinoma, Non-small Cell Lung

In brief

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.

Key facts

Study ID

NCT01514864

Run by

Bristol-Myers Squibb

People needed

19

Starts

2012-05-31

Expected to finish

2014-07-23

Last updated by the study team

2023-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• H. Lee Moffitt Cancer & Research Institute — Tampa, Florida, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Local Institution — Barretos, São Paulo, Brazil
• Local Institution — Barretos, São Paulo, Brazil
• Local Institution — S?o Paulo, São Paulo, Brazil
• Local Institution — São Paulo, Brazil
• The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
• Local Institution — Cologne, Germany
• Local Institution — Cologne, Germany
• Local Institution — Frankfurt, Germany
• Local Institution — Heidelberg, Germany
• Local Institution — Heidelberg, Germany
• Local Institution — Gdansk, Poland
• Local Institution — Lodz, Poland
• Local Institution — Warsaw, Poland
• Local Institution — Taipei, Taiwan
• Local Institution — Cambridge, Cambridgeshire, United Kingdom
• Local Institution — London, Greater London, United Kingdom
• Local Institution — Manchester, Greater Manchester, United Kingdom
• Local Institution — Gwent, Gwent, United Kingdom
• Local Institution — Edinburgh, Midlothian, United Kingdom
• Local Institution — Sutton, Surrey, United Kingdom
• Local Institution — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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