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

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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

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
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 |
Principal Investigator: | Mikael Eriksson, MD PhD | Scandinavian Sarcoma Group |
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 |
Clinical trial Investigational drugs Gastrointestinal stromal tumors Pazopanib |
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 |