Trial record 5 of 6 for:
((pazopanib AND GIST)OR Nct01391611 OR Nct01392352 OR NCT01339871 OR NCT01485042) | Open Studies
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (PAGIST)
This study is currently recruiting participants.
Verified January 2012 by Scandinavian Sarcoma Group
Sponsor:
Scandinavian Sarcoma Group
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
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
Further study details as provided by Scandinavian Sarcoma Group:
Primary Outcome Measures:
- 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
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 ] [ 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
| Estimated Enrollment: | 72 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Pazopanib
Two (2) tablets of 400 mg given once daily continuously
Other Name: Votrient
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524848
Contacts
| Contact: Mikael H Eriksson, MD, PhD | +46 46 171000 ext 77507 | mikael.eriksson@med.lu.se |
Locations
| Norway | |
| Dept of Oncology, Haukeland University Hospital | Recruiting |
| Bergen, Norway, N-5021 | |
| Contact: Dorota Goplen, MD +47 55979696 dgop@helse-bergen.no | |
| Principal Investigator: Dorota Goplen, MD | |
| Norwegian Radium Hospital | Recruiting |
| Oslo, Norway, N-0310 | |
| Contact: Kirsten Sundby Hall, MD +47 22 934000 k.s.hall@klinmed.uio.no | |
| Principal Investigator: Kirsten Sundby Hall, MD | |
| Dept of Oncology, Tromsö University Hospital | Recruiting |
| Tromsö, Norway, N-9038 | |
| Contact: Eivind Smeland, MD +47 77626788 eivind.smeland@unn.no | |
| Principal Investigator: Eivind Smeland, MD | |
| Dept of Oncology, St Olav Hospital | Recruiting |
| Trondheim, Norway, N-7006 | |
| Contact: Heidi Knobel, MD +47 73867830 heidi.knobel@stolav.no | |
| Principal Investigator: Heidi Knobel, MD | |
| Sweden | |
| Dept of Oncology, Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, SE-413 45 | |
| Contact: Katarina Engström, MD 046 31 3421000 katarina.engstrom@vgregion.se | |
| Principal Investigator: Katarina Engstrom, MD | |
| Dept of Oncology, Linköping University Hospital | Recruiting |
| Linköping, Sweden, SE-581 85 | |
| Contact: Najme Wall, MD +46 13 222000 najme.wall@lio.se | |
| Principal Investigator: Najme Wall, MD | |
| Dept of Oncology, Skane University Hospital | Recruiting |
| Lund, Sweden, SE-221 85 | |
| Contact: Mikael Eriksson, MD, PhD +46 46 177507 mikael.eriksson@med.lu.se | |
| Principal Investigator: Mikael H Eriksson, MD, PhD | |
| Sub-Investigator: Marie Ahlström, MD | |
| Radiumhemmet, Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, SE-171 76 | |
| Contact: Christina Linder Stragliotto, MD +46 8 517 70000 christina.linder-stragliotto@karolinska.se | |
| Principal Investigator: Christina Linder-Stragliotto, MD | |
| Dept of Oncology, Norrland University Hospital | Recruiting |
| Umeå, Sweden, SE-901 85 | |
| Contact: Karin Papworth, MD +46 90 7851000 karin.papworth@vll.se | |
| Principal Investigator: Karin Papworth, MD | |
| Dept of Oncology, Academic Hospital | Recruiting |
| Uppsala, Sweden, SE-751 85 | |
| Contact: Hans Hagberg, MD +46 46 6110000 hans.hagberg@akademiska.se | |
| Principal Investigator: Hans Hagberg, MD | |
Sponsors and Collaborators
Scandinavian Sarcoma Group
GlaxoSmithKline
More Information
No publications provided
| Responsible Party: | Scandinavian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT01524848 History of Changes |
| Other Study ID Numbers: | SSG XXI |
| Study First Received: | January 24, 2012 |
| Last Updated: | February 1, 2012 |
| Health Authority: | Sweden: Medical Products Agency Norway: Norwegian Medicines Agency Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Iceland: Icelandic Medicines Control Agency |
Keywords provided by Scandinavian Sarcoma Group:
|
Clinical trial Investigational drugs Gastrointestinal stromal tumors Pazopanib |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Imatinib Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013