Trial · NCT07116031
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: AUC | Cycle 1 Day 15 after the last participant dosed in the phase 1 part. | PK parameter (AUC at steady state) |
| Primary | Proportion of participants who achieve an overall response (partial response [PR] or complete response [CR]) by Week 25 or Cycle 7 Day 1 whichever is first | Last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study | Proportion of participants who achieve an overall response (partial response \[PR\] or complete response \[CR\]) with up to 24 weeks of therapy (i.e. by the Week 25 or Cycle 7 Day 1 visit whichever is first), as defined by the National Institute of Health (NIH) Consensus response criteria |
| Secondary | Phase 1: Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Up to 3 years after the last participant enrolled | Safety |
| Secondary | Phase 1: Cmax | Cycle 1 Day 15 after the last participant dosed in the phase 1 part | Steady-state belumosudil PK parameters |
| Secondary | Phase 1: AUC0-6h | Cycle 1 Day 15 after the last participant dosed in the phase 1 part | Steady-state belumosudil PK parameters |
| Secondary | Phase 1: ORR | last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study. | Proportion of participants who achieve an overall response (complete response \[CR\] or partial response \[PR\]) by 24 weeks, as defined by the 2014 National Institute of Health (NIH) Consensus response criteria |
| Secondary | Phase 1: DOR | Up to 3 years after the last participant enrolled | Time from the date of first response to the date of progression of cGVHD, initiation of a new systemic treatment for cGVHD, or death, whichever comes first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH Consensus response criteria |
| Secondary | Phase 1: response by organ | Up to 3 years after the last participant enrolled | As defined by the 2014 NIH Consensus response criteria |
| Secondary | Phase 1: failure-free survival (FFS) | Up to 3 years after the last participant enrolled | Time from the date of the first investigational medicinal product (IMP) administration to the date of initiation of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first |
| Secondary | Phase 1: overall survival (OS) | Up to 3 years after the last participant enrolled | Time from the date of first IMP administration to the date of death due to any cause |
| Secondary | Phase 1: time to response (TTR) | Up to 3 years after the last participant enrolled | Time from the date of the first IMP administration to the first documented response (either CR or PR) according to the 2014 NIH Consensus Criteria for cGVHD |
| Secondary | Phase 2: Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Up to 3 years after the last participant enrolled | Safety |
| Secondary | Phase 2: Ctrough of belumosudil | Cycle 2 Day 1 and Cycle 4 Day 1 after the last participant enrolled | |
| Secondary | Phase 2: DOR | Up to 3 years after the last participant enrolled | Time from first response to the date of progression of cGVHD, initiation of a new systemic treatment for cGVHD, or death, whichever comes first. DOR is determined only for participants who achieved overall response (PR or CR) as per NIH Consensus response criteria |
| Secondary | Phase 2: response by organ | Up to 3 years after the last participant enrolled | response by organ as defined by the 2014 NIH Consensus response criteria |
| Secondary | Phase 2: FFS | Up to 3 years after the last participant enrolled | Time from the date of the first IMP administration to the date of initiation of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first |
| Secondary | Phase 2: OS | Up to 3 years after the last participant enrolled | Time from the date of first IMP administration to the date of death due to any cause |
| Secondary | Phase 2: time to response (TTR) | Up to 3 years after the last participant enrolled | Time from the date of the first IMP administration to the first documented response (either CR or PR) according to the 2014 NIH Consensus Criteria for cGVHD |
| Secondary | Phase 1: time to next treatment (TTNT) | Up to 3 years after the last participant enrolled | Time from the date of the first IMP administration to initiating the next line of systemic therapy, or death whichever is first |
| Secondary | Phase 2: time to next treatment (TTNT) | Up to 3 years after the last participant enrolled | Time from the date of the first IMP administration to initiating the next line of systemic therapy, or death whichever is first |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07116031/registered