Gastrointestinal Stromal TumorsNCT01689376
Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed Access Program)
A study testing Regorafenib (BAY73-4506) in people with Gastrointestinal Stromal Tumors, run by Bayer.
Trial summary
The purpose of this Managed Access Program is to provide regorafenib to patients diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- 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 to 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- Signed Informed consent (IC) and data protection clarification obtained before any specific treatment related procedures. Patients or their legal representative must be able to understand and willing to sign a written IC.
- Male or female patients >= 18 years of age
- Patients 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of =< 1
- 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 regorafenib administration in the program. The treating physician or a designated associate is requested to advise the patient on how to achieve adequate birth control. Adequate contraception is defined in this program 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 regorafenib
- Pregnant or breast-feeding patients. 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 regorafenib.
- 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 regorafenib
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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's 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
- Patients with seizure disorder requiring medication
- History of organ allograft
- Patients 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 regorafenib
- 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 patient's participation in the program
- Known hypersensitivity to regorafenib, the drug class, or excipients in the formulation
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his / her compliance in the program
- Interstitial lung disease with ongoing signs and symptoms
- Persistent proteinuria of NCI-CTCAE v.4.0 Grade 3 (> 3.5 g/24 hours)
- Patients 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 within the last 30 days in a clinical trial
- Non-permissible concomitant medications and procedures (systemic anti-cancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy or any experimental therapies; Tyrosine Kinase Inhibitors (TKIs); bone marrow transplant or stem cell rescue; use of biologic response modifiers, such as granulocyte colony stimulating factor (G CSF), within 3 weeks prior to entering the program; St John's Wort; grapefruit and grapefruit juice; all traditional medicines with an anti-cancer indication)
About this study
Official title: Guidelines for Treatment With Regorafenib in Patients With Gastrointestinal Stromal Tumors (GIST) After Disease Progression on or Intolerance to Imatinib and Sunitinib (Managed Access Program)
The purpose of this Managed Access Program is to provide regorafenib to patients diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy.
Read the detailed description
This "Managed Access Program" covers the different types of programs in the participating countries (including compassionate use program, named patient program, cohorts e.g. ATU in France, etc).
- 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 drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 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)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689376
- Sponsor's protocol ID
- 16040
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2012
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidelines for Treatment With Regorafenib in Patients With Gastrointestinal Stromal Tumors (GIST) After Disease Progression on or Intolerance to Imatinib and Sunitinib (Managed Access Program)
- ClinicalTrials.gov ID
- NCT01689376
- Acronym / sponsor ID
- 16040
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 21 Sep 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 purpose of this Managed Access Program is to provide regorafenib to patients diagnosed with metastatic and / or unresectable GIST who have progressed after standard therapy.
Detailed description
This "Managed Access Program" covers the different types of programs in the participating countries (including compassionate use program, named patient program, cohorts e.g. ATU in France, etc).
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed consent (IC) and data protection clarification obtained before any specific treatment related procedures. Patients or their legal representative must be able to understand and willing to sign a written IC.
- Male or female patients >= 18 years of age
- Patients 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of =< 1
Key exclusion criteria (29 listed)
- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting regorafenib
- Pregnant or breast-feeding patients. 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 regorafenib.
- 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 | 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 16 Aug 2016.
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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 7 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 16 Aug 2016. 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 16 Aug 2016.