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Ph II CABOGIST in GIST | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Ph II CABOGIST in GIST

Phase II Study of Cabozantinib in Patients With Gastrointestinal Stromal Tumor (GIST) Who Progressed During Neoadjuvant, Adjuvant or Palliative Therapy With Imatinib and Sunitinib

NCT02216578•European Organisation for Research and Treatment of Cancer - EORTC

View on ClinicalTrials.gov

Summary

The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors. Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of GIST that is metastatic. Patients with the primary tumor still in place are excluded from the trial, due to the risk for intestinal perforation reported for cabozantinib.
•Presence of at least one non-previously irradiated, measurable metastatic lesion as defined by RECIST 1.1.
•Archival tumor tissue available from primary tumor or metastatic site (10 unstained slides with archived tumor tissue of 10 micrometer thickness and two hematoxylin and eosin (H\&E) stained slides) for central mutational analysis; Note: slides are preferred material but if not available blocks are accepted
•Failure on prior therapy with
•* Interval from prior TKI therapy to the first dose of cabozantinib should be at least 14 days
•* Radiological progression on imatinib during neoadjuvant, adjuvant or palliative treatment of GIST or within 3 months after completing adjuvant treatment with imatinib AND radiological progression on sunitinib for the treatment of advanced GIST
•Note: progression is assessed by local radiologist/oncologist without central confirmation of pre-baseline progression.
•Agreement of the patient to allow sequential sampling of circulating cell-free DNA for central mutational analysis is mandatory.
•Male or female patient ≥ 18 years of age
•ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0-1
+4 more criteria

Exclusion Criteria

•* Potassium, calcium, magnesium and phosphorous within normal limits of the institution or corrected to within normal limits prior to the first dose of study medication.
•* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min or GFR \>30 mL/min (as assessed per local standard).
•* Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with Gilbert's syndrome).
•* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within ≤ 3.0 x ULN.
•* Serum albumin ≥ 2.8 g/dL.
•* Serum lipase \< 2 x ULN and no radiologic or clinical evidence of pancreatitis
•* Urine protein/creatinine ratio (UPCR) ≤ 1.
•Clinically normal cardiac function based on the institutional lower limit of normal for left ventricular ejection fraction as assessed either by multi-gated acquisition scan or cardiac ultrasound, 12 lead ECG without clinically relevant abnormalities (stable atrial fibrillation allowed), no history of congenital long QT syndrome, no prolongation of corrected QT interval (QTcF) \> 500 msec according to Fridericia's formula), and no history of any one of the following cardiovascular conditions within the past 6 months:
•* Cardiac angioplasty or stenting.
•* Myocardial infarction.
+49 more criteria

Locations (11)

U.Z. Leuven - Campus Gasthuisberg (147)

Leuven, Belgium

University Hospital Motol (1905)

Prague, Czechia

Institut Bergonie (228)

Bordeaux, France

Centre Leon Berard (227)

Lyon, France

Gustave Roussy (225)

Villejuif, France

UniversitaetsMedizin Mannheim (527)

Mannheim, Germany

Military Hospital - State Health Centre (3769)

Budapest, Hungary

Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)

Bebington, United Kingdom

Royal Marsden Hospital - Chelsea, London (613)

Chelsea, United Kingdom

University College London Hospitals NHS Foundation Trust - University College Hospital (622)

London, United Kingdom

Key Dates

Start Date

February 2, 2017

Primary Completion Date

May 20, 2019

Completion Date

February 23, 2021

Last Updated

July 15, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Gastrointestinal Stromal Tumor

Interventions

cabozantinib

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Locally Advanced Gastrointestinal Stromal TumorLocally Advanced Sarcoma+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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