Trial · NCT03475953
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 37 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | PHASE I :PK - concentration peak for regorafenib. | Day 1 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as concentration peak for regorafenib |
| Secondary | PHASE I :PK - concentration peak for regorafenib. | Day 15 of cycle 2 (Each cycle is 28 days) | PK measurement expressed as concentration peak for regorafenib |
| Secondary | Phase I: Predictive blood biomarkers analysis (cytokines levels) by ELISA. | day 1 of cycles 1, 2, 4, 6 and at progression | levels of angiogenic and immunologic biomarkers in blood |
| Secondary | Phase I: Predictive blood biomarkers analysis (lymphocytes) by flow cytmetry. | day 1 of cycles 1, 2, 4, 6 and at progression | levels of angiogenic and immunologic biomarkers in blood |
| Secondary | Phase I: Predictive tumor growth factor biomarkers analysis by immunohistochemistry. | day 1 of cycle 1 and day 1 of cycle 2 | levels of angiogenic and immunologic biomarkers in tissue |
| Secondary | Phase I: Adverses events graded using the common toxicity criteria from the NCI v5 to determine the safety profile of regorafenib plus avelumab. | throughouth the treatment period, an average of 6 months | Toxicity graded using the common toxicity criteria from the NCI v5. |
| Secondary | PHASE II : 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 II : 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 II :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 II : 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 II : Assessment of the antitumor activity of regorafenib - Overall Survival | 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 II: Predictive blood biomarkers analysis (cytokines levels) by ELISA. | day 1 of cycles 1, 2, 4, 6 and at progression | levels of angiogenic and immunologic biomarkers in blood |
| Secondary | Phase II: Predictive blood biomarkers analysis (lymphocytes) by flow cytometry. | day 1 of cycles 1, 2, 4, 6 and at progression | levels of angiogenic and immunologic biomarkers in blood |
| Secondary | Phase II: Predictive tumor growth factor biomarkers analysis by immunohistochemistry. | day 1 of cycle 1 and day 1 of cycle 2 | levels of angiogenic and immunologic biomarkers in tissue |
| Secondary | Phase II: Adverses events graded using the common toxicity criteria from the NCI v5 to determine the safety profile of regorafenib plus avelumab | throughouth the treatment period, an average of 6 months | Toxicity graded using the common toxicity criteria from the NCI v5 |
| Secondary | Predictive metabolomic analysis by liquid chromatography-mass spectrometry | day 1 of cycles 1, 2, 4, 6 and at progression | Levels of metabolites in blood |
| Secondary | Phase II (cohort B): assessment of the antitumor activity of regorafenib | throughouth the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on CHOI criteria |
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.
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GET https://conductscience.org/api/trials/v1/NCT03475953/registered?page=2