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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01514864
Other study ID # CA180-385
Secondary ID 2011-003128-11
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 31, 2012
Est. completion date July 23, 2014

Study information

Verified date December 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date July 23, 2014
Est. primary completion date July 23, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria - 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. Exclusion Criteria - 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. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design


Intervention

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

Locations

Country Name City State
Brazil Local Institution Barretos Sao Paulo
Brazil Local Institution Barretos Sao Paulo
Brazil Local Institution S?o Paulo Sao Paulo
Brazil Local Institution Sao Paulo
Canada The Ottawa Hospital Cancer Centre Ottawa Ontario
Germany Local Institution Frankfurt
Germany Local Institution Heidelberg
Germany Local Institution Heidelberg
Germany Local Institution Koeln
Germany Local Institution Koeln
Poland Local Institution Gdansk
Poland Local Institution Lodz
Poland Local Institution Warsaw
Taiwan Local Institution Taipei
United Kingdom Local Institution Cambridge Cambridgeshire
United Kingdom Local Institution Cambridge
United Kingdom Local Institution Edinburgh Midlothian
United Kingdom Local Institution Gwent
United Kingdom Local Institution London Greater London
United Kingdom Local Institution Manchester Greater Manchester
United Kingdom Local Institution Sutton Surrey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau New York New York
United States H. Lee Moffitt Cancer & Research Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Germany,  Poland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Duration of Response (DOR) 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. From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Secondary Overall Survival 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. From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Secondary Progression-free Survival (PFS) Distribution 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 From Day 1 of study treatment to Week 12
Secondary Progression-free Survival (PFS) 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. From Day 1 of study treatment to Week 12
Secondary 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 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. From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Secondary Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality 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. From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
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