Clinical trial NCT01514864: Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Official title: Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-small Cell Lung
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
measure: Overall Survival
timeFrame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
measure: Progression-free Survival (PFS) Distribution
timeFrame: From Day 1 of study treatment to Week 12
measure: Progression-free Survival (PFS)
timeFrame: From Day 1 of study treatment to Week 12
measure: 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
timeFrame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
measure: Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
timeFrame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer & Research Institute
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: S?o Paulo
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Frankfurt
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Midlothian
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
city: Cambridge
country: United Kingdom
facility: Local Institution
city: Gwent
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: