Gastrointestinal Stromal TumorsPhase 2PAGISTNCT01524848
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
A Phase 2 study testing Pazopanib in people with Gastrointestinal Stromal Tumors, run by Scandinavian Sarcoma Group at 16 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Pazopanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Feb 2012to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Sweden6 sites
Dept of Oncology, Sahlgrenska University Hospital
Gothenburg, SE-413 45
Dept of Oncology, Linköping University Hospital
Linköping, SE-581 85
Dept of Oncology, Skane University Hospital
Lund, SE-221 85
Radiumhemmet, Karolinska University Hospital
Stockholm, SE-171 76
Dept of Oncology, Norrland University Hospital
Umeå, SE-901 85
Dept of Oncology, Academic Hospital
Uppsala, SE-751 85
Germany3 sites
Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg
Berlin, 13125
Universitätsklinikum Essen, Innere klinik und Poliklinik
Essen, DE-45122
Studienzentrale chirurgische klinik, Universitäts medizin Mannheim
Mannheim, DE-68167
Norway3 sites
Dept of Oncology, Haukeland University Hospital
Bergen, N-5021
Norwegian Radium Hospital
Oslo, N-0310
Dept of Oncology, St Olav Hospital
Trondheim, N-7006
Denmark2 sites
Aarhus University Hospital, dept. of Oncology
Aarhus, DK-8000 Aarhus C
Herlev Hospital, dept. of Oncology
Herlev, 2730
Finland2 sites
Helsinki University Hospital, dept. of oncology
Helsingfors, FI-00029
Kuopio University Hospital Cancer Center
Kuopio, FI-70029
About this study
Official title: 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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Pazopanib
- Keywords
- Clinical trial, Investigational drugs, Gastrointestinal stromal tumors, Pazopanib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
Two (2) tablets of 400 mg given once daily continuously
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | Single arm pazopanib Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment
Measured: Week 12
Secondary outcomes (5)
Progression free survival (PFS)
Progression free survival (KM analysis) for all patients administered the study drug
Measured: The patients will be followed for the duration of the trial treatment, an expected average of 6 months
DCR in relation to mutation
Disease control rate as described above in relation to the type of mutation of the primary tumor if this is available (not mandatory)
Measured: Week 12
DCR in relation to plasma concentration
Disease control rate as defined above in relation to the trough level (plasma concentration) of the study drug at week 12
Measured: Week 12
Toxicity
Recording of adverse events including SAE/SAR for all patients administered the study drug
Measured: The patients will be followed for the duration of the trial treatment + 1 month, an expected average of 7 months
Overall response rate
ORR = CR+PR at the time of best response during the study period
Measured: The patients will be followed for the duration of the trial treatment, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavian Sarcoma Group
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Mikael Eriksson, MD PhD, Principal investigator, Scandinavian Sarcoma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524848
- Sponsor's protocol ID
- SSG XXI
- Acronym
- PAGIST
- Status last verified
- May 2016
- First submitted
- 24 Jan 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
- ClinicalTrials.gov ID
- NCT01524848
- Acronym / sponsor ID
- PAGIST / SSG XXI
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Clinical trial, Investigational drugs, Gastrointestinal stromal tumors, Pazopanib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Scandinavian Sarcoma GroupUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Drug: PazopanibSingle arm pazopanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: VotrientTwo (2) tablets of 400 mg given once daily continuously | Drug | Open label |
Primary outcome
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
5 secondary outcomes
Progression free survival (PFS)
Time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months
DCR in relation to mutation
Time frame: Week 12
DCR in relation to plasma concentration
Time frame: 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
Overall response rate
Time frame: The patients will be followed for the duration of the trial treatment, an expected average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Eriksson, MD PhD principal investigator
Scandinavian Sarcoma Group
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Gastrointestinal Stromal Tumors, run by Scandinavian Sarcoma Group at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Sweden, Germany, Norway, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.