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

NCT ID: NCT01514864

Last Updated: 2023-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-23

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-small Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression

Dasatinib, 140 mg (NSCLC With DDR2 Mutation)

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

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression

Interventions

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Dasatinib

Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau

New York, New York, United States

Site Status

Local Institution

Barretos, São Paulo, Brazil

Site Status

Local Institution

Barretos, São Paulo, Brazil

Site Status

Local Institution

S?o Paulo, São Paulo, Brazil

Site Status

Local Institution

São Paulo, , Brazil

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Local Institution

Cologne, , Germany

Site Status

Local Institution

Cologne, , Germany

Site Status

Local Institution

Frankfurt, , Germany

Site Status

Local Institution

Heidelberg, , Germany

Site Status

Local Institution

Heidelberg, , Germany

Site Status

Local Institution

Gdansk, , Poland

Site Status

Local Institution

Lodz, , Poland

Site Status

Local Institution

Warsaw, , Poland

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Local Institution

Cambridge, Cambridgeshire, United Kingdom

Site Status

Local Institution

London, Greater London, United Kingdom

Site Status

Local Institution

Manchester, Greater Manchester, United Kingdom

Site Status

Local Institution

Gwent, Gwent, United Kingdom

Site Status

Local Institution

Edinburgh, Midlothian, United Kingdom

Site Status

Local Institution

Sutton, Surrey, United Kingdom

Site Status

Local Institution

Cambridge, , United Kingdom

Site Status

Countries

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Russia South Korea United States Brazil Canada Germany Poland Taiwan United Kingdom

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2011-003128-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA180-385

Identifier Type: -

Identifier Source: org_study_id