check_circleStudy Completed

Gastrointestinal stromal tumors

Bayer Identifier:

14874

ClinicalTrials.gov Identifier:

NCT01271712

EudraCT Number:

2009-017957-37

EU CT Number:

Not Available
Study of regorafenib as a 3rd-line or beyond treatment for gastrointestinal stromal tumors (GIST)

Trial purpose

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.
The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.
Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.
Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review.
Subjects receiving placebo who experience disease progression may be offered active treatment.
Subjects who experience progression during regorafenib treatment may continue open label treatment.
All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib therapy. Additionally, disease progression or intolerance to other systemic therapies, as well as investigational new agents, is allowed, except prior treatment with any other vascular endothelial growth factor receptor (VEGFR) inhibitor.
    - Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment.
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    - Adequate bone marrow, liver, and renal function as assessed by laboratory parameters.
    Recovery to NCI-CTCAE v4.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure-related toxicity (except alopecia and anemia).
  • - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
    -Congestive heart failure New York Heart Association (NYHA) class 2.
    - Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
    - Uncontrolled hypertension (systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
    Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before start of study drug or venous thrombotic events such as deep vein thrombosis within the 3 months before start of study drug.
    - Ongoing infection grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
    Symptomatic metastatic brain or meningeal tumors.
    - Subjects with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event NCI-CTCAE version 4.0 grade 3 or higher within 4 weeks prior to the start of study drug.
    Non-healing wound, ulcer, or bone fracture.
    - Persistent proteinuria of NCI-CTCAE version 4.0 grade 3 or higher (3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample).

Trial summary

Enrollment Goal
199
Trial Dates
January 2011 - April 2019
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bad Saarow, 15526, Germany
Completed
Köln, 50924, Germany
Completed
Essen, 45122, Germany
Completed
Mannheim, 68167, Germany
Completed
Seoul, 138-736, Korea, Republic Of
Completed
Busan, 49201, Korea, Republic Of
Completed
Tel Aviv, 64239, Israel
Withdrawn
Beer Sheva, 84101, Israel
Withdrawn
Beijing, 100142, China
Completed
Shanghai, 200030, China
Withdrawn
Shanghai, 200025, China
Withdrawn
Chengdu, 610041, China
Completed
Singapore, 169610, Singapore
Completed
LEUVEN, 3000, Belgium
Withdrawn
Edegem, 2650, Belgium
Completed
Graz, 8036, Austria
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Seoul, 03080, Korea, Republic Of
Completed
Seoul, 06351, Korea, Republic Of
Completed
Goyang-si, 410-769, Korea, Republic Of
Completed
Hannover, 30625, Germany
Completed
Tübingen, 72076, Germany
Withdrawn
Barcelona, 08041, Spain
Completed
Leiden, 2333 ZA, Netherlands
Completed
Helsinki, 00290, Finland
Completed
Lyon Cedex 08, 69373, France
Completed
Bordeaux Cedex, 33076, France
Withdrawn
Marseille, 13385, France
Completed
LILLE CEDEX, 59020, France
Completed
Milano, 20133, Italy
Completed
Torino, 10060, Italy
Completed
Bologna, 40138, Italy
Withdrawn
Oulu, 90020, Finland
Completed
Warszawa, 02-781, Poland
Completed
London, SW3 6JJ, United Kingdom
Completed
Toronto, M5G 1X5, Canada
Withdrawn
Montreal, H3G 1A4, Canada
Withdrawn
Lausanne, 1011, Switzerland
Withdrawn
Zürich, 8091, Switzerland
Completed
Boston, 02115, United States
Completed
New York, 10065, United States
Withdrawn
Palo Alto, 94304-1207, United States
Completed
Portland, 97239-2964, United States
Completed
Philadelphia, 19111-2497, United States
Completed
Seattle, 98109, United States
Withdrawn
Aurora, 80045, United States
Withdrawn
Salt Lake City, 84112, United States
Completed
Evanston, 60201, United States
Completed
Skokie, 60076, United States
Withdrawn
Miami, 33125, United States
Withdrawn
Birmingham, 35294-0001, United States
Withdrawn
La Jolla, 92093-1503, United States
Completed
Minneapolis, 55455, United States
Completed
Nanjing, 210002, China
Completed
Guangzhou, 510060, China
Completed
Manchester, M20 4BX, United Kingdom
Completed
Kashiwa, 277-8577, Japan
Completed
Niigata, 951-8520, Japan
Completed
Osaka, 543-0035, Japan
Completed
Chuo-ku, 104-0045, Japan
Completed
Edmonton, T6G 1Z2, Canada
Completed
London, N6A 4L6, Canada
Completed
Leicester, LE1 5WW, United Kingdom
Withdrawn
Dallas, 75390, United States
Withdrawn
Cambridge, CB2 0QQ, United Kingdom
Withdrawn
Baltimore, 21231, United States
Completed
Sapporo, 060-8648, Japan
Withdrawn
Matsuyama, 791-0280, Japan
Withdrawn
Kumamoto, 860-8556, Japan
Withdrawn
Madrid, 28034, Spain
Completed
Barcelona, 08035, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Withdrawn
Valencia, 46009, Spain
Completed
Nagoya, 466-8650, Japan
Withdrawn
Firenze, 50134, Italy
Completed
Palermo, 90127, Italy
Withdrawn
Bari, 70124, Italy
Withdrawn
Milano, 20089, Italy
Completed
Düsseldorf, 40479, Germany
Completed
VILLEJUIF, 94805, France
Withdrawn
Besancon, 25030, France
Withdrawn
Saint Herblain Cedex, 44805, France
Completed
NIJMEGEN, 6525 GA, Netherlands
Withdrawn
ROTTERDAM, 3015 CE, Netherlands
Withdrawn
Atlanta, 30322, United States
Withdrawn
Tampa, 33612, United States
Completed
Scottsdale, 85258, United States
Completed
Beijing, 100071, China

Primary Outcome

  • Progression-free Survival
    date_rangeTime Frame:
    From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival
    date_rangeTime Frame:
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately one year
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression (TTP)
    date_rangeTime Frame:
    From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Tumor Response
    date_rangeTime Frame:
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Objective response rate
    date_rangeTime Frame:
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.
    enhanced_encryption
    Safety Issue:
    No
  • Disease Control Rate (DCR)
    date_rangeTime Frame:
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response (DOR)
    date_rangeTime Frame:
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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