Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

NCT ID: NCT01524848

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-11-30

Brief 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.

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label

Single arm pazopanib

Group Type: OTHER

Pazopanib

Intervention Type: DRUG

Two (2) tablets of 400 mg given once daily continuously

Interventions

Pazopanib

Two (2) tablets of 400 mg given once daily continuously

Intervention Type: DRUG

Other Intervention Names

Votrient

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Scandinavian Sarcoma Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikael Eriksson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Scandinavian Sarcoma Group

Locations

Aarhus University Hospital, dept. of Oncology

Aarhus, , Denmark

Herlev Hospital, dept. of Oncology

Herlev, , Denmark

Helsinki University Hospital, dept. of oncology

Helsingfors, , Finland

Kuopio University Hospital Cancer Center

Kuopio, , Finland

Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg

Berlin, , Germany

Universitätsklinikum Essen, Innere klinik und Poliklinik

Essen, , Germany

Studienzentrale chirurgische klinik, Universitäts medizin Mannheim

Mannheim, , Germany

Dept of Oncology, Haukeland University Hospital

Bergen, , Norway

Norwegian Radium Hospital

Oslo, , Norway

Dept of Oncology, St Olav Hospital

Trondheim, , Norway

Dept of Oncology, Sahlgrenska University Hospital

Gothenburg, , Sweden

Dept of Oncology, Linköping University Hospital

Linköping, , Sweden

Dept of Oncology, Skane University Hospital

Lund, , Sweden

Radiumhemmet, Karolinska University Hospital

Stockholm, , Sweden

Dept of Oncology, Norrland University Hospital

Umeå, , Sweden

Dept of Oncology, Academic Hospital

Uppsala, , Sweden

Countries

Denmark; Finland; Germany; Norway; Sweden

Other Identifiers

SSG XXI

Identifier Type: -

Identifier Source: org_study_id