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

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01514864
First received: January 18, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to identify if patients with malignancy harboring a Discoidin Domain Receptor 2 (DDR2) mutation or an inactivating B-RAF mutation will respond to Dasatinib.


Condition Intervention Phase
Carcinoma, Non-small Cell Lung
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response in responding subjects, by stratum is defined as the time from the first assessment in which response (PR or CR) is documented until the first assessment at which disease progression is documented [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) rate at 12 weeks of treatment is defined as the proportion of subjects that have no documentation of disease progression at a specified timepoint [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Overall PFS distribution in subjects, by stratum is defined as the time from treatment start date to the earliest evidence of disease progression or death. Subjects who do not progress or die will be censored on the date of their last tumor assessment [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Safety and tolerability of Dasatinib will be assessed using descriptive summaries of adverse events and laboratory abnormalities [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
  • Overall survival in subjects, by stratum [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: August 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratum A: Dasatinib
NSCLC with inactivating B-RAF mutation
Drug: Dasatinib
Tablet, Oral, 140 mg, Once daily until unacceptable toxicity or disease progression
Experimental: Stratum C: Dasatinib
NSCLC of squamous type with DDR2 mutation
Drug: Dasatinib
Tablet, Oral, 140 mg, Once daily until unacceptable toxicity or disease progression
Experimental: Stratum D: Dasatinib
Malignancy of any other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having candidate B-RAF mutation not functionally characterized
Drug: Dasatinib
Tablet, Oral, 140 mg, Once daily until unacceptable toxicity or disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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 with DDR2 mutation
    • Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation which is not functionally characterized
  • 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 and DDR2 mutation 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514864

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Florida
H. Lee Moffitt Cancer & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Eric Haura, Site 010    813-745-6827      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Paul Paik, Site 023    212-639-2153      
Brazil
Local Institution Recruiting
Barretos, Sao Paulo, Brazil, 14784-400
Contact: Site 018         
Local Institution Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Site 017         
Canada, Ontario
Local Institution Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0033         
Germany
Local Institution Recruiting
Frankfurt, Germany, 60488
Contact: Site 020         
Local Institution Recruiting
Heidelberg, Germany, 69126
Contact: Site 019         
Local Institution Suspended
Heidelberg, Germany, 69120
Local Institution Suspended
Koeln, Germany, 50924
Local Institution Recruiting
Koeln, Germany, 50931
Contact: Site 024         
Korea, Republic of
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Site 014         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Site 015         
Poland
Local Institution Recruiting
Gdansk, Poland, 80-219
Contact: Site 005         
Local Institution Recruiting
Lodz, Poland, 93-509
Contact: Site 026         
Local Institution Recruiting
Warsaw, Poland, 02-781
Contact: Site 007         
Taiwan
Local Institution Recruiting
Taipei, Taiwan, 112
Contact: Site 016         
United Kingdom
Local Institution Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Site 0034         
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 030         
Local Institution Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Contact: Site 028         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0035         
Local Institution Recruiting
Gwent, United Kingdom, NP20 2UB
Contact: Site 032         
Local Institution Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Site 029         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01514864     History of Changes
Other Study ID Numbers: CA180-385, 2011-003128-11
Study First Received: January 18, 2012
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Taiwan : Food and Drug Administration
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014