A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy (AXAGIST)
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ClinicalTrials.gov Identifier: NCT04258956 |
Recruitment Status : Unknown
Verified February 2020 by Maria Sklodowska-Curie National Research Institute of Oncology.
Recruitment status was: Recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
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Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Information provided by (Responsible Party):
Maria Sklodowska-Curie National Research Institute of Oncology
Tracking Information | |||||||
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First Submitted Date ICMJE | February 3, 2020 | ||||||
First Posted Date ICMJE | February 6, 2020 | ||||||
Last Update Posted Date | February 6, 2020 | ||||||
Actual Study Start Date ICMJE | April 30, 2019 | ||||||
Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Participants Achieving 3-Month Progression-Free Survival (PFSR) Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: 12 weeks ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy | ||||||
Official Title ICMJE | A Phase II, Single Arm Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy - AXAGIST | ||||||
Brief Summary | To assess anti-tumor activity of avelumab in combination with axitinib in patients with unresectable/metastatic GIST after progression on second or third line treatment (after failure on at least of imatinib and sunitinib) in terms of progression-free survival (PFS) | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Gastrointestinal Stromal Tumors | ||||||
Intervention ICMJE | Drug: Axitinib
Avelumab 10 mg/kg will be administered every two weeks. Avelumab is administered as a 1-hour iv infusion, diluted with 0.9% saline solution; Axitinib 5 mg should be taken orally twice daily approximately 12 hours apart with or without food. They should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. The duration of treatment cycle is 28 days. Other Name: Avelumab
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Study Arms ICMJE | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
58 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 30, 2023 | ||||||
Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Poland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04258956 | ||||||
Other Study ID Numbers ICMJE | AXAGIST | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Maria Sklodowska-Curie National Research Institute of Oncology | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Maria Sklodowska-Curie National Research Institute of Oncology | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Maria Sklodowska-Curie National Research Institute of Oncology | ||||||
Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |