TerminatedPhase 2NCT01514864
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDasatinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: Dasatinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  • 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.
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • H. Lee Moffitt Cancer & Research InstituteTampa, Florida
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering NassauNew York, New York
  • Local InstitutionBarretos, São Paulo
  • Local InstitutionBarretos, São Paulo
  • Local InstitutionS?o Paulo, São Paulo
  • Local InstitutionSão Paulo
  • The Ottawa Hospital Cancer CentreOttawa, Ontario
  • Local InstitutionCologne
  • Local InstitutionCologne
  • Local InstitutionFrankfurt
  • Local InstitutionHeidelberg

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2023. Always confirm current availability with the study team.

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