Trial Outcomes & Findings for Epacadostat and Pembrolizumab in Patients With GIST (NCT NCT03291054)
NCT ID: NCT03291054
Last Updated: 2024-06-11
Results Overview
The primary endpoint is the overall response rate as defined as the best response using RECIST v1.1 criteria. A standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger. To use RECIST, there must be at least one tumor that can be measured on x-rays, CT scans, or MRI scans. The types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (SD). Also called Response Evaluation Criteria In Solid Tumors.
TERMINATED
PHASE2
1 participants
within the first 24 weeks of the start of study therapy
2024-06-11
Participant Flow
Participant milestones
| Measure |
Epacadostat and Pembrolizumab
Subjects will receive epacadostat and pembrolizumab
Pembrolizumab: Subjects will receive pembrolizumab 200 mg (flat dose) IV every 3 weeks on day 1 of a 21 day cycle.
Epacadostat: Epacadostat will be dosed at 100 mg PO twice a day (BID) daily. Doses should be taken twice daily, in the morning and evening, approximately 12 hours apart, without regard to food.Doses will be self-administered, except on Cycle 2 Day 1, when the morning dose will be given at the study site clinic. Subjects will be required to keep a pill diary that will be provided to them.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epacadostat and Pembrolizumab in Patients With GIST
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: within the first 24 weeks of the start of study therapyPopulation: Data was not analyzed or disclosed in an effort to protect subject confidentiality (n=1).
The primary endpoint is the overall response rate as defined as the best response using RECIST v1.1 criteria. A standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger. To use RECIST, there must be at least one tumor that can be measured on x-rays, CT scans, or MRI scans. The types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (SD). Also called Response Evaluation Criteria In Solid Tumors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time from registration up to 2 yearsPopulation: Data was not analyzed or disclosed in an effort to protect subject confidentiality (n=1).
The length of time from the start of treatment that patients diagnosed with the disease are still alive.
Outcome measures
Outcome data not reported
Adverse Events
Epacadostat and Pembrolizumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.
- Publication restrictions are in place
Restriction type: OTHER