A phase 1 study of pimitespib and imatinib in patients with GIST
Phase 1
Recruiting
- Conditions
- GIST
- Registration Number
- JPRN-jRCT2011210044
- Lead Sponsor
- Sato Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Provided written informed consent
- Histologically confirmed GIST
- Progressed on the basis of imaging during or within 6 months of the last imatinib administration at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria
- Received treatment with any other line of therapy besides imatinib for advanced GIST; including local surgery and radiotherapy
- A serious illness or medical condition
- Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study
- Pregnancy or lactation (including lactation interruption)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method < Dose Escalation Part ><br>Dose-limiting toxicity (DLT) and MTD of pimitespib in combination with imatinib<br><br>< Expansion Part ><br>Progression-free survival (PFS) by the independent radiological review
- Secondary Outcome Measures
Name Time Method Adverse event, Adverse drug reaction, Laboratory abnormalities