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Phase II trial of dasatinib in subjects 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 Pharmacogenetics Blood Amendment 1; Revised Protocol 02 incorporating amendment 05

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003128-11-DE
Enrollment
73
Registered
2012-01-12
Start date
2012-05-09
Completion date
Unknown
Last updated
2015-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-small cell lung MedDRA version: 14.1 Level: LLT Classification code 10007284 Term: Carcinoma System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864

Interventions

Product Name: DASATINIB Product Code: BMS-354825 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DASATINIB CAS Number: 302962-49-8 Current Sponsor code: BMS-354825 Concentration unit: mg

Sponsors

Bristol-Myers Squibb International Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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, despite supplementation - Creatinine > 3 x ULN - Total bilirubin > 1.5 x ULN - ALT > 3 x ULN

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of this study is to identify if patients with malignancy harboring a DDR2 mutation or an inactivating B-RAF mutation will respond to dasatinib ;Secondary Objective: 1) duration of response in responding subjects, by stratum; 2) progression-free survival (PFS) rate at 12 weeks of treatment (assessed at Week 13) and overall PFS distribution in subjects, by stratum; 3) overall survival in subjects, by stratum; 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

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

Countries

Brazil, Canada, Germany, Poland, Taiwan, United Kingdom, United States

Contacts

Public ContactEU Start Up Department

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026