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

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,485

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 19 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Study arms

• 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

  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

  Drug: Dasatinib

Interventions

• DrugDasatinib

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

Primary outcomes

1. 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.

   Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

Secondary outcomes

1. 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.

   Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

2. 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.

   Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

3. 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

   Time frame: From Day 1 of study treatment to Week 12

4. 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.

   Time frame: From Day 1 of study treatment to Week 12

5. 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.

   Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

6. 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.

   Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first

Baseline characteristics

3 further baseline measures are reported on the registry.

Related links

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