Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
- Registration Number
- NCT01514864
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib 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 Dasatinib, 140 mg (NSCLC With DDR2 Mutation) Dasatinib 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
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) From enrollment of last patient to 24 months or until all patients have died, whichever occurs first 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) From enrollment of last patient to 24 months or until all patients have died, whichever occurs first DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.
Overall Survival From enrollment of last patient to 24 months or until all patients have died, whichever occurs first Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.
Progression-free Survival (PFS) Distribution From Day 1 of study treatment to Week 12 PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method
Progression-free Survival (PFS) From Day 1 of study treatment to Week 12 PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality From enrollment of last patient to 24 months or until all patients have died, whichever occurs first Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: \<8.0 - 6.5 g/dL, \<4.9-4.0 mmol/L, \<80-65 g/L. Alkaline phosphatase, Grade 3: \>5.0-20.0\*upper limit of normal (ULN). Total bilirubin, Grade 3: \>3.0-10.0\*ULN. Calcium, low, Grade 3: \<7.0-6.0 mg/dL, \<1.75-1.5 mmol/L.
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 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.
Trial Locations
- Locations (5)
H. Lee Moffitt Cancer & Research Institute
🇺🇸Tampa, Florida, United States
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Local Institution
🇬🇧Gwent, United Kingdom
Memorial Sloan Kettering Nassau
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States