Trial · NCT03475953
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PHASE I : Recommended phase II dose (RP2D) | During the first cycle (28 days) | Recommended phase II dose (RP2D) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Primary | PHASE II (7cohorts A, C, D, E, F and G) : Assessment of the antitumor activity of regorafenib | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on objective response under treatment defined as CR or PR following RECIST v1.1 criteria. |
| Primary | Phase II (cohorts B, H, I, M, N, O and P): Assessment of the antitumor activity of regorafenib | 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on 6-month progression-free rate, defined as CR, PR and SD following RECIST v1.1 criteria. |
| Primary | Phase II (cohort A'): Assessment of the antitumor activity of regorafenib | 4 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on 4-months progression-free rate, defined as CR, PR and SD following RECIST v1.1 criteria. |
| Secondary | PHASE I : Maximum Tolerated Dose (MTD) | During the first cycle (28 days) | Maximum Tolerated Dose (MTD) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Secondary | PHASE I : Dose Limiting Toxicities (DLT) | During the first cycle (28 days) | Dose Limiting Toxicities (DLT) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Secondary | PHASE I : Toxicity | Throughout the treatment period, an average of 6 months | Toxicity graded using the common toxicity criteria from the NCI v5. |
| Secondary | PHASE I : Assessment of the antitumor activity of regorafenib - Best overall response | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of best overall response as per RECIST v1.1. |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - objective response rate under treatment | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of objective response rate under treatment (ORR) defined as CR or PR as per RECIST v1.1. |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - objective response rate | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of objective response rate at 6-months (ORR) defined as CR or PR as per RECIST v1.1. |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - non-progression | 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of 6-months non-progression defined as CR, PR or SD as per RECIST v1.1 |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - progression-free survival (PFS) | 1 year | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of 1-year progression-free survival (PFS) as per RECIST v1.1. |
| Secondary | PHASE I : Assessment of the antitumor activity of regorafenib - overall survival (OS) | 1 year | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of 1-year overall survival (OS) as per RECIST v1.1. |
| Secondary | PHASE I :Pharmacocinetics (PK) - Area Under Curve (AUC) | Day 15 of cycle 1 (Each cycle is 28 days) | PK measurement expressed as Area Under Curve (AUC) for regorafenib. |
| Secondary | PHASE I :Pharmacocinetics (PK) - Area Under Curve (AUC) | Day 1 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as Area Under Curve (AUC) for regorafenib. |
| Secondary | PHASE I :Pharmacocinetics (PK) - Area Under Curve (AUC) | Day 15 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as Area Under Curve (AUC) for regorafenib. |
| Secondary | PHASE I :Pharmacocinetics (PK) - half-life for regorafenib. | Day 15 of cycle 1 (Each cycle is 28 days) | PK measurement expressed as half-life for regorafenib. |
| Secondary | PHASE I :Pharmacocinetics (PK) - half-life for regorafenib. | Day 1 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as half-life for regorafenib. |
| Secondary | PHASE I :Pharmacocinetics (PK) - half-life for regorafenib. | Day 15 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as half-life for regorafenib. |
| Secondary | PHASE I :PK - concentration peak for regorafenib. | Day 15 of cycle 1 (Each cycle is 28 days) | PK measurement expressed as concentration peak for regorafenib |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03475953/registered