Trial · NCT02520427
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Day 1 to Day 14 | A participant was not DLT-evaluable if they dropped out before completion of the DLT window (14 days) for reasons other than an adverse event related to study drug or the participant had not received investigational product (IP) treatment for at least 14 days at the target dose for a 3- or 4-week cycle or at least 7 days at a target dose for a 2- week cycle. Furthermore, following drug interruptions, if a participant was unable to complete 2 repeat cycles for reasons other than DLT, the participant was not DLT evaluable. |
| Primary | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days | The severity of TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. The general guideline for assessment ranged from Grade 1 to 5, with higher grades indicating a worse outcome, and included: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death. |
| Secondary | Number of Participants Who Experienced an Incident of Anti-AMG 330 Antibody Formation | Baseline until the end of study, up to approximately 6 months | Number of participants with a binding anti-body positive result at any timepoint post-baseline who had a negative or no result at baseline. |
| Secondary | Response Rate in Participants With R/R AML | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Response for participants with R/R AML was defined as the percentage of participants with complete response (CR)/complete remission with incomplete count recovery (CRi)/morphologic leukemia-free state (MLFS) \[per modified international working group (IWG) criteria\] or complete remission with partial hematologic recovery (CRh). |
| Secondary | Response Rate in Participants With MRD-positive AML | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Response for participants with MRD-positive AML was defined as the percentage of participants with a conversion from MRD+ status with 0.1% threshold to CRMDR- or CRiMD-. |
| Secondary | Response Rate in Participants With MDS | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Response for participants with MDS was defined as the percentage of participants with CR or marrow complete remission per IWG. |
| Secondary | Duration of Response | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Duration of response was defined as the interval from the date of the first disease assessment indicating an overall response to the first documented relapse, disease progression, or death due to any cause, whichever occurs first. |
| Secondary | Time to Response | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Time to response was defined as the interval from the first administration of AMG 330 to the first documentation of response. |
| Secondary | Event-free Survival | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Event-free survival was defined as the interval from first administration of AMG 330 to the earliest of date of treatment failure, relapse for responders, or death due to any cause. |
| Secondary | Overall Survival | Baseline until the end of study, up to approximately 6 months | Overall survival was defined as the time from enrollment until death due to any cause. |
| Secondary | 14 Day Infusion Duration: Terminal Half Life (t1/2 z) of AMG 330 | 14 day infusion duration: Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days) | |
| Secondary | 28 Day Infusion Duration: t1/2 z of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days) | |
| Secondary | 14 Day Infusion Duration: Steady State Serum Concentration After End of Infusion (Css) of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days) | |
| Secondary | 28 Day Infusion Duration: Css After End of Infusion of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days) | |
| Secondary | 14 Day Infusion Duration: Volume of Distribution at Steady State (Vz) of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days) | |
| Secondary | 28 Day Infusion Duration: Vz of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 day) | |
| Secondary | 14 Day Infusion Duration: Clearance at Steady State (CL) for AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days) | |
| Secondary | 28 Day Infusion Duration: CL of AMG 330 | Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days) |
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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