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Clinical Trials/EUCTR2014-000501-13-GB
EUCTR2014-000501-13-GBActive, not recruitingPhase 1

Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib - Ph II CABOGIST in GIST

European Organisation for Research and Treatment of Cancer (EORTC)0 sites41 target enrollmentStarted: February 17, 2017Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
41
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •?Histologically confirmed diagnosis of GIST that is metastatic.
  • •? Presence of at least one non-previously irradiated, measurable metastatic lesion as defined by RECIST 1.1
  • •?Radiographic absence of a cavitating pulmonary lesion within 28 days prior to the first dose of cabozantinib
  • •?Consent of the patient
  • •?Failure on prior therapy with imatinib and sunitinib
  • •?Male or female patient = 18 years of age
  • •?ECOG performance status (PS) of 0-1
  • •?Adequate bone marrow and organ function prior to receiving the first dose of study treatment
  • •?Clinically normal cardiac function
  • •?Patients must be able to swallow and retain oral film-coated tablets
  • •?Recovery to baseline or = Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments
  • •?Prior radiation therapy patients with clinically relevant ongoing complications from prior radiation therapy are not eligible
  • •?Prior surgery:
  • •- minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment is permitted
  • •- Patients with clinically relevant ongoing complications from prior surgery are not eligible
  • •? Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • •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 15
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

  • •?evidence of tumor or metastatic lesion invading the gastrointestinal tract within 28 days prior to the first dose of cabozantinib
  • •?current evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
  • •?Patient with tumor in contact with, invading or encasing a major blood vessel
  • •?Prior use of tyrosine kinase inhibitors for the treatment of advanced GIST with the exception of imatinib and sunitinib
  • •?Other investigational agents within 28 days before the first dose of study treatment
  • •?History of congenital long QT syndrome
  • •?QTcF> 500 msec within 1 month before the first dose of study treatment
  • •?Congestive heart failure
  • •?History of unstable angina, clinically significant cardiac arrhythmias and myocardial infarction within 6 months prior to the first dose of protocol treatment
  • •?Poorly controlled hypertension
  • •?Concomitant anticoagulation at therapeutic doses with oral anticoagulants
  • •?Specific contraindications for treatment with cabozantinib
  • •?stroke and thromboembolic event requiring therapeutic anticoagulation within 6 months before the first dose of study treatment
  • •?Gastrointestinal disorders associated with a high risk of perforation or fistula formation
  • •?Evidence of significant active bleeding or bleeding diathesis within 6 months before the first dose of study treatment
  • •?Hemoptysis = 0.5 teaspoon of red blood within 3 months before the first dose of study treatment
  • •?Signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • •?Prior radiation therapy:
  • •-radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before the first dose of study treatment.
  • •-systemic treatment with radionuclides within 6 weeks before the first dose of study treatment.
  • •?Prior surgery major surgery or trauma within 12 weeks prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer.
  • •? Active infection requiring systemic treatment within 28 days before the first dose of study treatment.
  • •? History of organ transplant.
  • •? Concurrent severe, clinically relevant hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
  • •?History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non-metastatic, non-melanoma skin cancer
  • •?Patients requiring chronic concomitant treatment with strong Cytochrome P450 (CYP) 3A4 inducers
  • •?Lactating females

Investigators

Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)

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