Trial · NCT04973605
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to 28 days | DLTs will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and will include most grade 3 or higher events, as defined in the protocol. |
| Primary | Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation and Adverse Events of Special Interest (AESIs). | Up to 30 days after last dose of study drug | |
| Primary | Part 2: Overall response rate (ORR) as Assessed by Investigator | Approximately 4 years | Defined as the percentage of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) criteria |
| Primary | Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator | Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years] | Defined as the percentage of participants with a documented VGPR or better (including sCR, CR, and VGPR) |
| Primary | Part 2: Complete Response (CR) or Stringent Complete Response (sCR) as Assessed by Investigator | Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]) | defined as the percentage of participants with a documented CR or sCR |
| Secondary | Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUClast) After a Single Dose of Sonrotoclax | Cycle 1 (each cycle is up to 28 days) | |
| Secondary | Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax | Cycle 1 (each cycle is up to 28 days) | |
| Secondary | Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax | Cycle 1 (each cycle is up to 28 days) | |
| Secondary | Part 1: At Steady-state: AUC last, ss | Cycle 2 (each cycle is up to 28 days) | |
| Secondary | Part 1: At Steady-state: Cmax, ss | Cycle 2 (each cycle is up to 28 days) | |
| Secondary | Part 1: At Steady-state: trough plasma concentration (Ctrough) ss | Cycle 2 (each cycle is up to 28 days) | |
| Secondary | Part 1: At Steady-state: time to reach Cmax (tmax,ss) | Cycle 2 (each cycle is up to 28 days) | |
| Secondary | Part 2: Time to response (TTR) as Assessed by Investigator | Approximately 4 years | TTR is defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to first documentation of response of Partial Response (PR) or better |
| Secondary | Part 2: Duration of response (DOR) as Assessed by Investigator | Approximately 4 years | DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause, whichever occurs first. DOR will be analyzed only for patients who have achieved an overall response of at least PR. The distribution of DOR will be summarized by the Kaplan-Meier method. |
| Secondary | Part 2: Progression-free survival (PFS) as Assessed by Investigator | Approximately 4 years | PFS is defined as time from start of treatment （for nonrandomized cohorts） or date of randomization （for randomized cohorts） to the first documentation of disease progression or death, whichever occurs first |
| Secondary | Part 2: Overall survival (OS) as Assessed by Investigator | Approximately 4 years | OS defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to the date of death due to any cause |
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/NCT04973605/registered