Trial · NCT04445701
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: MTD / RP2D of AO-176 assessed by incidence of dose-limiting toxicities and incidence of treatment-related adverse events (TEAEs) as assessed by CTCAE v5.0 | 12 months | Safety and tolerability of AO-176 when administered as monotherapy and in combination with dexamethasone or with dexamethasone plus bortezomib in adult patients with R/R MM as assessed by incidence of DLTs and TEAEs as assessed by CTCAE v5.0 |
| Primary | Phase 2: Objective response rate (ORR) of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on ORR using International Myeloma Working Group (IMWG) uniform response criteria |
| Secondary | Phase 1: ORR of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on ORR using IMWG uniform response criteria |
| Secondary | Phase 1: Duration of response (DOR) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on DOR using IMWG uniform response criteria |
| Secondary | Phase 1: Disease control rate (DCR) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on DCR using IMWG uniform response criteria |
| Secondary | Phase 1: Progression-free survival (PFS) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on PFS using IMWG uniform response criteria |
| Secondary | Phase 1: Overall survival (OS) of single agent AO-176 | 12 months | Evaluate the clinical activity of single agent AO-176 based on OS |
| Secondary | Phase 2: DOR of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on DOR using IMWG uniform response criteria |
| Secondary | Phase 2: DCR of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on DCR using IMWG uniform response criteria |
| Secondary | Phase 2: PFS of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on PFS using IMWG uniform response criteria |
| Secondary | Phase 2: OS of AO-176 + DEX + BORT | 12 months | Evaluate the clinical activity of AO-176 + dexamethasone + bortezomib based on OS |
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/NCT04445701/registered