Gastrointestinal Stromal TumorsNCT01646593
Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy
A study testing Regorafenib (BAY73-4506) in people with Gastrointestinal Stromal Tumors, run by Bayer.
Trial summary
The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy. Selected additional safety information on regorafenib will be collected and progression-free survival (PFS) will be estimated. 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?
- Regorafenib (BAY73-4506)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Male or female subjects >= 18 years of age
- Subjects with histologically confirmed metastatic and / or unresectable GIST
- At least imatinib and sunitinib as prior treatment regimens with progression on or intolerance to imatinib and sunitinib
- Adequate bone marrow, liver and renal function
- Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
Who cannot join
- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug.
- Congestive heart failure >= New York Heart Association (NYHA) class 2
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before start of study drug
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- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
- Pleural effusion or ascites that causes respiratory compromise (National Cancer Institute Common terminology criteria for adverse events [NCI-CTCAE] v. 4.0 Grade >= 2 dyspnea)
- Ongoing infection NCI-CTCAE v. 4.0 Grade > 2
- Known history of human immunodeficiency virus (HIV) infection
- Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
- Subjects with seizure disorder requiring medication
- History of organ allograft
- Subjects with evidence or history of any bleeding diathesis, irrespective of severity
- Any hemorrhage or bleeding event NCI-CTCAE v. 4.0 Grade >= 3 within 4 weeks prior to the start of study medication
- Non-healing wound, ulcer, or bone fracture
- Renal failure requiring hemo- or peritoneal dialysis
- Dehydration NCI-CTCAE v. 4.0 Grade >= 1
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Known hypersensitivity to the study drug, study drug class, or excipients in the formulation
- Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his / her compliance in the study
- Interstitial lung disease with ongoing signs and symptoms
- Persistent proteinuria of NCI-CTCAE v. 4.0 Grade 3 (> 3.5 g/24 hours)
- Subjects unable to swallow oral medications
- Any malabsorption condition
- Unresolved toxicity higher than NCI-CTCAE v. 4.0 Grade 1 (excluding alopecia, anaemia,and hypothyroidism) attributed to any prior therapy / procedure
- Concomitant participation or participation in another therapeutic trial with investigational new drugs within 30 days or 5 drug half-lives (if drug half life in subjects is known), whichever is shorter
- If any other approved tyrosine kinase inhibitor was given within 1 week or a minimum of 5 drug half-lives whichever is longer (i.e. within 7 days for imatinib, or within 10 days for sunitinib)
About this study
Official title: An Open-label Expanded Access Program of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GIST) After Disease Progression on or Intolerance to Imatinib and Sunitinib
The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy.
Selected additional safety information on regorafenib will be collected and progression-free survival (PFS) will be estimated.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Regorafenib (BAY73-4506)
- 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.
Regorafenib (BAY73-4506)Drug
160 mg BAY73-4506, 3 weeks on drug, 1 week off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
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 BayerThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646593
- Sponsor's protocol ID
- 16339
- Status last verified
- Dec 2014
- First submitted
- 18 Jul 2012
- Last updated
- 15 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Expanded Access Program of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GIST) After Disease Progression on or Intolerance to Imatinib and Sunitinib
- ClinicalTrials.gov ID
- NCT01646593
- Acronym / sponsor ID
- 16339
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 20 Jul 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.
The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy.
Selected additional safety information on regorafenib will be collected and progression-free survival (PFS) will be estimated.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects >= 18 years of age
- Subjects with histologically confirmed metastatic and / or unresectable GIST
- At least imatinib and sunitinib as prior treatment regimens with progression on or intolerance to imatinib and sunitinib
- Adequate bone marrow, liver and renal function
- Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
Key exclusion criteria (29 listed)
- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug.
- Congestive heart failure >= New York Heart Association (NYHA) class 2
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
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 |
|---|---|---|
| Regorafenib (BAY73-4506)160 mg BAY73-4506, 3 weeks on drug, 1 week off | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A study testing Regorafenib (BAY73-4506) in people with Gastrointestinal Stromal Tumors, run by Bayer.
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 5 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
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 15 Dec 2014.