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

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ClinicalTrials.gov Identifier: NCT01514864
Recruitment Status : Terminated (Lack of efficacy and slow accrual)
First Posted : January 23, 2012
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

January 18, 2012
January 23, 2012
July 23, 2015
December 3, 2015
December 3, 2015
May 2012
July 2014   (Final data collection date for primary outcome measure)
Objective Response Rate (ORR) [ Time Frame: 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.
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 ]
Complete list of historical versions of study NCT01514864 on ClinicalTrials.gov Archive Site
  • Duration of Response (DOR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 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 [ Time Frame: 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.
  • Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality [ Time Frame: 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.
  • 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 ]
  • 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 ]
  • 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 ]
  • Safety and tolerability of Dasatinib will be assessed using descriptive summaries of adverse events and laboratory abnormalities [ Time Frame: Month 24 ]
  • Overall survival in subjects, by stratum [ Time Frame: Month 24 ]
Not Provided
Not Provided
 
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-small Cell Lung
Drug: Dasatinib
Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression
  • Experimental: Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
    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
    Intervention: Drug: Dasatinib
  • Experimental: Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
    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
    Intervention: Drug: Dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
95
July 2014
July 2014   (Final data collection date for primary outcome measure)

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:

    • NSCLC with inactivating B-RAF mutation
    • NSCLC with discoidin domain receptor 2 (DDR2) mutation
    • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Germany,   Poland,   Taiwan,   United Kingdom,   United States
Korea, Republic of,   Russian Federation
 
NCT01514864
CA180-385
2011-003128-11 ( EudraCT Number )
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP