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

This study is currently recruiting participants. (see Contacts and Locations)
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: June 12, 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: May 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514864

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Florida
H. Lee Moffitt Cancer & Research Institute Completed
Tampa, Florida, United States, 33612
United States, New York
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
Brazil
Local Institution Terminated
Barretos, Sao Paulo, Brazil, 14784
Local Institution Terminated
S?o Paulo, Sao Paulo, Brazil, 05403
Canada, Ontario
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Laurie, Site 0033    613-737-7700 ext 70308      
Germany
Local Institution Active, not recruiting
Frankfurt, Germany, 60488
Local Institution Suspended
Heidelberg, Germany, 69120
Local Institution Completed
Heidelberg, Germany, 69126
Local Institution Active, not recruiting
Koeln, Germany, 50931
Local Institution Suspended
Koeln, Germany, 50924
Korea, Republic of
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Site 015         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Site 014         
Poland
Local Institution Not yet recruiting
Gdansk, Poland, 80-219
Contact: Site 005         
Local Institution Not yet recruiting
Lodz, Poland, 93-509
Contact: Site 026         
Local Institution Not yet recruiting
Warsaw, Poland, 02-781
Contact: Site 007         
Taiwan
Local Institution Completed
Taipei, Taiwan, 112
United Kingdom
Local Institution Active, not recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Local Institution Active, not recruiting
London, Greater London, United Kingdom, SW3 6JJ
Local Institution Active, not recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Local Institution Active, not recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Local Institution Active, not recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Local Institution Completed
Gwent, United Kingdom, NP20 2UB
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: June 12, 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 July 10, 2014