Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
This study is currently recruiting participants.
Verified September 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01514864
First received: January 18, 2012
Last updated: March 28, 2013
Last verified: September 2012
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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
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 of squamous type with DDR2 mutation
- Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC or melanoma 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 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, 10022 | |
| Contact: Paul Paik, Site 023 646-888-2395 | |
| Brazil | |
| Local Institution | Recruiting |
| Barretos, Sao Paulo, Brazil, 14784 | |
| Contact: Site 018 | |
| Canada, Ontario | |
| Local Institution | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Site 0033 | |
| Germany | |
| Local Institution | Suspended |
| Heidelberg, Germany, 69120 | |
| Local Institution | Recruiting |
| Heidelberg, Germany, 69126 | |
| Contact: Site 019 | |
| Local Institution | Recruiting |
| Koeln, Germany, 50931 | |
| Contact: Site 024 | |
| Local Institution | Suspended |
| Koeln, Germany, 50924 | |
| Korea, Republic of | |
| Local Institution | Recruiting |
| Daegu, Korea, Republic of, 705-717 | |
| Contact: Site 017 | |
| 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 | |
| Taiwan | |
| Local Institution | Recruiting |
| Taipei, Taiwan, 112 | |
| Contact: Site 016 | |
| United Kingdom | |
| Local Institution | Not yet recruiting |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| Contact: Site 0034 | |
| Local Institution | Not yet recruiting |
| London, Greater London, United Kingdom, SW3 6JJ | |
| Contact: Site 030 | |
| Local Institution | Not yet recruiting |
| Edinburgh, Midlothian, United Kingdom, EH4 2XU | |
| Contact: Site 028 | |
| Local Institution | Not yet 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: | March 28, 2013 |
| 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 May 16, 2013