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

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ClinicalTrials.gov Identifier: NCT01524848
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):
Scandinavian Sarcoma Group

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Pazopanib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
Study Start Date : February 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Open label
Single arm pazopanib
Drug: Pazopanib
Two (2) tablets of 400 mg given once daily continuously
Other Name: Votrient

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524848

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Aarhus University Hospital, dept. of Oncology
Aarhus, Denmark, DK-8000 Aarhus C
Herlev Hospital, dept. of Oncology
Herlev, Denmark, 2730
Helsinki University Hospital, dept. of oncology
Helsingfors, Finland, FI-00029
Kuopio University Hospital Cancer Center
Kuopio, Finland, FI-70029
Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg
Berlin, Germany, 13125
Universitätsklinikum Essen, Innere klinik und Poliklinik
Essen, Germany, DE-45122
Studienzentrale chirurgische klinik, Universitäts medizin Mannheim
Mannheim, Germany, DE-68167
Dept of Oncology, Haukeland University Hospital
Bergen, Norway, N-5021
Norwegian Radium Hospital
Oslo, Norway, N-0310
Dept of Oncology, St Olav Hospital
Trondheim, Norway, N-7006
Dept of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 45
Dept of Oncology, Linköping University Hospital
Linköping, Sweden, SE-581 85
Dept of Oncology, Skane University Hospital
Lund, Sweden, SE-221 85
Radiumhemmet, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Dept of Oncology, Norrland University Hospital
Umeå, Sweden, SE-901 85
Dept of Oncology, Academic Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Scandinavian Sarcoma Group
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Principal Investigator: Mikael Eriksson, MD PhD Scandinavian Sarcoma Group
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Responsible Party: Scandinavian Sarcoma Group
ClinicalTrials.gov Identifier: NCT01524848    
Other Study ID Numbers: SSG XXI
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2016
Keywords provided by Scandinavian Sarcoma Group:
Clinical trial
Investigational drugs
Gastrointestinal stromal tumors
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases