Gastrointestinal Stromal TumorsPhase 2NCT00570635
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
A Phase 2 study testing XL820 in people with Gastrointestinal Stromal Tumors and Gastrointestinal Neoplasms, run by Exelixis at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
- What is being tested?
- XL820
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2007to May 2009
- 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
- Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2
- Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
- Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
- Adequate organ and marrow function
- Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
Who cannot join
- Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
- Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
- Anticoagulation with warfarin or coumarin-related compounds
- Radiation to ≥25% of bone marrow within 28 days of study entry
- Treatment with other investigational agents within 28 days of the first dose of XL820
- Known central nervous systems metastases
Show all 9Show fewer
- Uncontrolled or intercurrent illness
- Pregnancy or breast-feeding
- Active bacterial or viral infection requiring systemic treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts, 02115
Study site
Los Angeles, California, 90095
Study site
Park Ridge, Illinois, 60068
About this study
Official title: A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib
The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.
- Being tested
- XL820
- Keywords
- GIST, Gastrointestinal Cancer
- Medical subject headings
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL820Drug
XL820 capsules administered orally as a single agent at a dose of 800 mg daily
XL820Drug
XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: XL820 |
| B | Experimental | Not described Receives: Drug: XL820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
Measured: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
Secondary outcomes (3)
Safety and tolerability of XL820
Measured: Assessed at each visit
Progression-free survival, duration of response, and overall survival
Measured: Assessed until progression
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Measured: Assessed during periodic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
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.
- More trials run by ExelixisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570635
- Sponsor's protocol ID
- XL820-201
- Status last verified
- May 2013
- First submitted
- 7 Dec 2007
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib
- ClinicalTrials.gov ID
- NCT00570635
- Acronym / sponsor ID
- XL820-201
- Keywords
- GIST, Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Dec 2007 (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.
The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: XL820 |
| B | Experimental | Drug: XL820 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2
- Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
- Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
- Adequate organ and marrow function
Key exclusion criteria (9 listed)
- Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
- Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
- Anticoagulation with warfarin or coumarin-related compounds
- Radiation to ≥25% of bone marrow within 28 days of study entry
- Treatment with other investigational agents within 28 days of the first dose of XL820
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 |
|---|---|---|
| XL820XL820 capsules administered orally as a single agent at a dose of 800 mg daily | Drug | A |
| XL820XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily | Drug | B |
Primary outcome
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
Time frame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
3 secondary outcomes
Safety and tolerability of XL820
Time frame: Assessed at each visit
Progression-free survival, duration of response, and overall survival
Time frame: Assessed until progression
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Time frame: Assessed during periodic visits
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 7 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XL820 in people with Gastrointestinal Stromal Tumors and Gastrointestinal Neoplasms, run by Exelixis at 3 sites in United States.
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 7 inclusion and 9 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 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib (time frame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter). 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 7 Jun 2013.