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: 14.1Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-12
• Last Update Posted: 16 March 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 (ie, other than SNPs), defined as follows:
i) NSCLC with inactivating B-RAF mutation
ii) Malignant melanoma 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 or melanoma 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 firstline, 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to identify if patients with malignancy harboring a DDR2 mutation or an inactivating B-RAF mutation<br>will respond to dasatinib<br>;Secondary Objective: 1) duration of response in responding subjects, by stratum;<br>2) progression-free survival (PFS) rate at 12 weeks of treatment (assessed at Week 13) and overall PFS distribution in subjects, by stratum; <br>3) overall survival in subjects, by stratum;<br>4) describe the safety and tolerability of dasatinib in this setting;Primary end point(s): Objective Response Rate, by stratum;Timepoint(s) of evaluation of this end point: LPLV

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) duration of response in responding subjects, by stratum;<br>2) progression-free survival (PFS) rate at 12 weeks of treatment (assessed at Week 13) and overall PFS distribution in subjects, by stratum; <br>3) overall survival in subjects, by stratum;<br>4) describe the safety and tolerability of dasatinib in this setting;Timepoint(s) of evaluation of this end point: 1) LPLV<br>2) LPLV<br>3) LPLV<br>4) LPLV