NCT01514864

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
7 countries

24 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 3, 2015

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

January 18, 2012

Results QC Date

July 23, 2015

Last Update Submit

December 17, 2023

Conditions

Carcinoma, Non-small Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter \[LD\] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.

    From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

Secondary Outcomes (6)

  • Duration of Response (DOR)

    From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

  • Overall Survival

    From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

  • Progression-free Survival (PFS) Distribution

    From Day 1 of study treatment to Week 12

  • Progression-free Survival (PFS)

    From Day 1 of study treatment to Week 12

  • Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation

    From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

  • +1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Dasatinib

Dasatinib, 140 mg (NSCLC With DDR2 Mutation)

EXPERIMENTAL

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

Drug: Dasatinib

Interventions

DasatinibDRUG

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

Dasatinib, 140 mg (NSCLC With DDR2 Mutation)Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

New York, New York, 10065, United States

Location

Local Institution

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution

Barretos, São Paulo, 14784, Brazil

Location

Local Institution

S?o Paulo, São Paulo, 05403, Brazil

Location

Local Institution

São Paulo, 01246-000, Brazil

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Cologne, 50924, Germany

Location

Local Institution

Cologne, 50931, Germany

Location

Local Institution

Frankfurt, 60488, Germany

Location

Local Institution

Heidelberg, 69120, Germany

Location

Local Institution

Heidelberg, 69126, Germany

Location

Local Institution

Gdansk, 80-219, Poland

Location

Local Institution

Lodz, 93-509, Poland

Location

Local Institution

Warsaw, 02-781, Poland

Location

Local Institution

Taipei, 112, Taiwan

Location

Local Institution

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Local Institution

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Local Institution

Gwent, Gwent, NP20 2UB, United Kingdom

Location

Local Institution

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

Local Institution

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Local Institution

Cambridge, CB2 2QQ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Limitations and Caveats

The study was terminated due to lack of efficacy and slow enrollment of patients.

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

May 31, 2012

Primary Completion

July 23, 2014

Study Completion

July 23, 2014

Last Updated

December 19, 2023

Results First Posted

December 3, 2015

Record last verified: 2023-12

Locations

DE(5)PL(3)BR(4)TW(1)GB(7)US(3)CA(1)