Phase II trial of dasatinib in subjects with advanced cancers harboring DDR2 mutation or inactivating B-RAF mutatio

• Conditions: Carcinoma, Non-small cell lung; MedDRA version: 16.1Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003128-11-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

a) Diagnosis of advanced malignancy, NSCLC only during stage 1 of accrual
b) Non-synonymous mutation of B-RAF or DDR2, defined as follows:
i) NSCLC with inactivating B-RAF mutation
iii) NSCLC with DDR2 mutation
iv) Malignancy of other histology with DDR2 mutation or inactivating B-RAF
mutation, or NSCLC having a B-RAF mutation which is not functionally characterized
c) At least one target lesion per RECIST 1.1 criteria on baseline staging evaluation
d) Disease progression after = 1 prior treatment regimen
i) Exception: Subjects with NSCLC of squamous type and DDR2 mutation may be enrolled in first line, no prior treatment is required

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i) Pleural or pericardial effusion Grade > 1
i) QTcF > 470 msec (Grade = 2) or diagnosed congenital long QT syndrome
- Absolute granulocyte count < 1,500/mm3
-Hemoglobin < 10 g/dL
- Platelet count < 75,000/mm3
- Serum calcium < LLN - Hypokalemia, hypophosphatemia or hypomagnesemia Grade > 1, despite
supplementation
- Creatinine > 3 x ULN
- Total bilirubin > 1.5 x ULN
- ALT > 3 x ULN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified