A randomised phase II trial of imatinib alternating withregorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST) - ALT GIST

European Organisation for Research and Treatment of Cancer0 sites240 target enrollmentSeptember 11, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 11, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

European Organisation for Research and Treatment of Cancer

•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 have at least 1 lesion
•which is ? 2 cm in size).
•7\. Adequate bone marrow function (Haemoglobin ? 9\.0g/dL, platelet count ? 100 x 109/L, and absolute neutrophil count ? 1\.5 x 109/L).
•8\. Adequate liver function (Serum total bilirubin ?1\.5 x ULN, INR ? 1\.5, and ALT, AST, ALP ?2\.5 x ULN (? 5 x ULN for participants with liver metastases). Lipase level must be ? 1\.5 x ULN.
•9\. Adequate renal function (Creatinine clearance \> 50ml/min) based on either the Cockcroft Gault formula, 24 hour urine or Glomerular Filtration Rate (GFR scan); and serum creatinine ? 1\.5 x ULN.

•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 use of an anticoagulant such as warfarin within 6 months prior to randomisation.
•9\. Poorly controlled hypertension (systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management).
•10\. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or non healing wound, ulcer or fracture.