Gastrointestinal Stromal TumorsPhase 2NCT01091207
Sorafenib for Imatinib/Sunitinib-failed GIST
A Phase 2 study testing Sorafenib in people with Gastrointestinal Stromal Tumors, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). 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?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Aug 2011
- 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
Who may be able to join
- age over 18 years
- advanced GIST
- failed (progressed and/or intolerable) after prior treatments for GIST
- ECOG performance status of 0~2
- resolution of all toxic effects of prior treatments
- no prior radiotherapy within 1 month before registration
Show all 9Show fewer
- measurable lesion as defined by RECIST
- adequate marrow, hepatic, renal and cardiac functions
- provision of a signed written informed consent
Who cannot join
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- history of other malignancies
- active CNS disease not controllable with radiotherapy or corticosteroids
- active and uncontrollable bleeding from gastrointestinal tract
- prior history of sorafenib use
- gastrointestinal obstruction or malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib
With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.
Read the detailed description
This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.
Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Sorafenib
- Keywords
- Sorafenib, GIST, Refractory, advanced GIST failed after both imatinib and sunitinib
- 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.
SorafenibDrug
The patients will receive daily oral administration of sorafenib 400 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | The patients will receive daily oral administration of sorafenib 400 mg twice daily. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-control rate
Measured: Six months after registration
Secondary outcomes (1)
Response rate
Measured: Every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean GIST Study Group
- Investigators
- Se Hoon Park, MD, Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091207
- Sponsor's protocol ID
- 2009-08-102
- Status last verified
- Jan 2012
- First submitted
- 30 Nov 2009
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec;30(6):2377-83. doi: 10.1007/s10637-012-9795-9. Epub 2012 Jan 25.
PubMed 22270258
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib
- ClinicalTrials.gov ID
- NCT01091207
- Acronym / sponsor ID
- 2009-08-102
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Sorafenib, GIST, Refractory, advanced GIST failed after both imatinib and sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korean GIST Study Group
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Mar 2010 (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.
With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.
Detailed description
This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.
Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: SorafenibThe patients will receive daily oral administration of sorafenib 400 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age over 18 years
- advanced GIST
- failed (progressed and/or intolerable) after prior treatments for GIST
- ECOG performance status of 0~2
- resolution of all toxic effects of prior treatments
Key exclusion criteria (7 listed)
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- history of other malignancies
- active CNS disease not controllable with radiotherapy or corticosteroids
- active and uncontrollable bleeding from gastrointestinal tract
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 |
|---|---|---|
| SorafenibThe patients will receive daily oral administration of sorafenib 400 mg twice daily. | Drug | Sorafenib |
Primary outcome
Disease-control rate
Time frame: Six months after registration
1 secondary outcome
Response rate
Time frame: Every 2 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 20 Jan 2012.
- Derived from this study: PubMed 22270258Park SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec;30(6):2377-83. doi: 10.1007/s10637-012-9795-9. Epub 2012 Jan 25.
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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.
Se Hoon Park, MD principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Gastrointestinal Stromal Tumors, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. 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 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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: Six months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091207, which also lists 1 linked publication.
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 20 Jan 2012.