Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed Access Program)

NCT01689376 | Unknown

• 1 other identifier: 16040
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastrointestinal Stromal Tumors

Interventions

Regorafenib (BAY73-4506) DRUG

160 mg BAY73-4506, 3 weeks on drug, 1 week off drug

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: September 21, 2012
• Last Updated: August 16, 2016

Record last verified: 2016-08