Overview

This trial is active, not recruiting.

Condition gastrointestinal stromal tumors
Treatment pazopanib
Phase phase 2
Targets VEGF, PDGF, KIT
Sponsor Scandinavian Sarcoma Group
Collaborator GlaxoSmithKline
Start date February 2012
End date January 2015
Trial size 72 participants
Trial identifier NCT01524848, SSG XXI

Summary

Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single arm pazopanib
pazopanib Votrient
Two (2) tablets of 400 mg given once daily continuously

Primary Outcomes

Measure
Disease control rate
time frame: Week 12

Secondary Outcomes

Measure
Progression free survival (PFS)
time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months
DCR in relation to mutation
time frame: Week 12
DCR in relation to plasma concentration
time frame: Week 12
Toxicity
time frame: The patients will be followed for the duration of the trial treatment + 1 month, an expected average of 7 months
Overall response rate
time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Eligibility Criteria: - Metastatic and/or locally advanced GIST, with diagnosis based on histology with positive c-kit and/or DOG-1, or with a GIST-typical mutation in KIT or PDGFR - Measurable disease on CT (computed tomography) as defined by RECIST criteria; at least one measurable lesion not given radiotherapy - History of progressive disease on CT according to RECIST criteria after both imatinib and sunitinib treatment, and also after nilotinib if this drug has been given - No other TKIs given than imatinib, sunitinib and nilotinib - Age at least 18 years at the time of diagnosis of GIST - WHO performance status 0-2 - Resolution of all toxic side effects from earlier TKI treatment and any other potential non-TKI treatment to grade 1 or below - Sufficient organ functions as defined in the protocol - Absence of earlier or present certain other conditions as defined in the protocol - No pregnancy or lactation - Women with childbearing potential must accept the use of adequate contraception throughout the study period - Written informed consent

Additional Information

Official title Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
Principal investigator Mikael Eriksson, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Scandinavian Sarcoma Group.