Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (PAGIST)
This study has been completed.
Sponsor:
Scandinavian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT01524848
First Posted: February 2, 2012
Last Update Posted: May 10, 2017
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Scandinavian Sarcoma Group
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Gastrointestinal Stromal Tumors | Drug: Pazopanib | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Soft Tissue Sarcoma
Genetic and Rare Diseases Information Center resources:
Soft Tissue Sarcoma
Gastrointestinal Stromal Tumors
U.S. FDA Resources
Further study details as provided by Scandinavian Sarcoma Group:
Primary Outcome Measures:
- 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:
- 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
- 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)
- 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
- 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
- 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
| Estimated Enrollment: | 72 |
| Study Start Date: | February 2012 |
| Study Completion Date: | November 2016 |
| Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Open label
Single arm pazopanib
|
Drug: Pazopanib
Two (2) tablets of 400 mg given once daily continuously
Other Name: Votrient
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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
Locations
| Denmark | |
| Aarhus University Hospital, dept. of Oncology | |
| Aarhus, Denmark, DK-8000 Aarhus C | |
| Herlev Hospital, dept. of Oncology | |
| Herlev, Denmark, 2730 | |
| Finland | |
| Helsinki University Hospital, dept. of oncology | |
| Helsingfors, Finland, FI-00029 | |
| Kuopio University Hospital Cancer Center | |
| Kuopio, Finland, FI-70029 | |
| Germany | |
| 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 | |
| Norway | |
| 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 | |
| Sweden | |
| 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
GlaxoSmithKline
Investigators
| Principal Investigator: | Mikael Eriksson, MD PhD | Scandinavian Sarcoma Group |
More Information
| Responsible Party: | Scandinavian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT01524848 History of Changes |
| Other Study ID Numbers: |
SSG XXI |
| First Submitted: | January 24, 2012 |
| First Posted: | February 2, 2012 |
| Last Update Posted: | May 10, 2017 |
| Last Verified: | May 2016 |
Keywords provided by Scandinavian Sarcoma Group:
|
Clinical trial Investigational drugs Gastrointestinal stromal tumors Pazopanib |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |