NL-OMON56311
Recruiting
Phase 2
A randomised phase II trial of imatinib alternating with;regorafenib compared to imatinib alone for the first line ;treatment of advanced gastrointestinal stromal tumour (GIST) - ALT GIST
European Organisation for Research in Treatment of Cancer (EORTC)0 sites18 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- gastrointestinal stromal tumour
- Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults (over 18 yrs) with histologically confirmed GIST. In CD\*117\*negative
- •cases DOG\*1 must be positive or a KIT/PDGFRA mutation must be present., 2\.
- •Unresectable, metastatic disease., 3\. No prior TKI for metastatic disease, with
- •the exception of those patients who have had up to 21 days of uninterrupted
- •treatment on 400mg daily of imatinib., 4\. Imatinib therapy given as an adjuvant
- •treatment and completed at least 3 months prior to entry into this trial is
- •permitted. Patients who have progression of GIST while on adjuvant therapy are
- •not eligible for this trial., 5\. ECOG performance status 0\*2, 6\. Measurable
- •disease by RECIST version 1\.1\. (Note: Participants with only peritoneal disease
- •will be eligible only if they have lesions measurable in two dimensions and
Exclusion Criteria
- •1\. Concurrent GI illness which may prevent absorption of imatinib or
- •regorafenib \- please note that prior gastrectomy or bowel resection does not
- •exclude patients from this study., 2\. Use of other investigational drugs within
- •4 weeks prior to enrolment., 3\. Known sensitivity to any of the study drugs,
- •study drug classes, or excipients in the formulation., 4\. Participants
- •receiving therapeutic doses of warfarin., 5\. Presence of brain metastases., 6\.
- •The presence of PDGFR D842V mutation or other mutation known to cause imatinib
- •resistance., 7\. Inability to swallow tablets., 8\. Arterial thrombotic or
- •ischaemic events, such as cerebrovascular accident or pulmonary embolism within
- •6 months prior to randomisation; or major venous thrombotic events requiring
Outcomes
Primary Outcomes
Not specified
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