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

Primary Purpose

Gastrointestinal Stromal Tumors

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Regorafenib (BAY73-4506)
Sponsored by
Bayer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Gastrointestinal Stromal Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2012
    Last Updated
    December 12, 2014
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01646593
    Brief Title
    Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayer

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Stromal Tumors

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Regorafenib (BAY73-4506)
    Intervention Description
    160 mg BAY73-4506, 3 weeks on drug, 1 week off

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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