check_circleStudy Completed
Gastrointestinal stromal tumors
Bayer Identifier:
14874
ClinicalTrials.gov Identifier:
EudraCT Number:
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.
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
BothAge
18 - N/ATrial summary
Enrollment Goal
199Trial Dates
January 2011 - April 2019Phase
Phase 3Could I Receive a placebo
YesProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 Survivaldate_rangeTime Frame:From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall Survivaldate_rangeTime Frame:From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately one yearenhanced_encryptionNoSafety Issue:
- 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 yearenhanced_encryptionNoSafety Issue:
- Tumor Responsedate_rangeTime Frame:From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 yearenhanced_encryptionNoSafety Issue:
- Objective response ratedate_rangeTime Frame:From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.enhanced_encryptionNoSafety Issue:
- 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 yearenhanced_encryptionNoSafety Issue:
- 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 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2