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Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (PAGIST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Scandinavian Sarcoma Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Scandinavian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT01524848
First received: January 24, 2012
Last updated: February 1, 2012
Last verified: January 2012

January 24, 2012
February 1, 2012
February 2012
January 2014   (final data collection date for primary outcome measure)
Disease control rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment
Same as current
Complete list of historical versions of study NCT01524848 on ClinicalTrials.gov Archive Site
  • Progression free survival (PFS) [ Time Frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months ] [ Designated as safety issue: No ]
    Progression free survival (KM analysis) for all patients administered the study drug
  • DCR in relation to mutation [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Disease control rate as described above in relation to the type of mutation of the primary tumor if this is available (not mandatory)
  • DCR in relation to plasma concentration [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Disease control rate as defined above in relation to the trough level (plasma concentration) of the study drug at 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 ] [ Designated as safety issue: Yes ]
    Recording of adverse events including SAE/SAR for all patients administered the study drug
  • Overall response rate [ Time Frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months ] [ Designated as safety issue: No ]
    ORR = CR+PR at the time of best response during the study period
Same as current
Not Provided
Not Provided
 
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
Drug: Pazopanib
Two (2) tablets of 400 mg given once daily continuously
Other Name: Votrient
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mikael H Eriksson, MD, PhD +46 46 171000 ext 77507 mikael.eriksson@med.lu.se
Norway,   Sweden
 
NCT01524848
SSG XXI
Yes
Scandinavian Sarcoma Group
Scandinavian Sarcoma Group
GlaxoSmithKline
Not Provided
Scandinavian Sarcoma Group
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP