Skip to main content
OpenTrials
Completed

NCT Number: NCT01524848

Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, dept. of Oncology, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pazopanib

Drug

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

Other names: Votrient

Primary outcomes

  1. Disease control rate

    Time frame: Week 12

    The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months

    Progression free survival (KM analysis) for all patients administered the study drug

  2. DCR in relation to mutation

    Time frame: Week 12

    Disease control rate as described above in relation to the type of mutation of the primary tumor if this is available (not mandatory)

  3. DCR in relation to plasma concentration

    Time frame: Week 12

    Disease control rate as defined above in relation to the trough level (plasma concentration) of the study drug at week 12

  4. Toxicity

    Time frame: The patients will be followed for the duration of the trial treatment + 1 month, an expected average of 7 months

    Recording of adverse events including SAE/SAR for all patients administered the study drug

  5. Overall response rate

    Time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months

    ORR = CR+PR at the time of best response during the study period

Sponsors and collaborators

Lead sponsor

Scandinavian Sarcoma Group

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group

Acronym: PAGIST

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 2, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.