Trial · NCT02520427
A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
NCT02520427, Phase 1, Terminated, Amgen; results first posted 2024-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies. Trials, record NCT02520427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02520427
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
- NCT number
- NCT02520427
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 95 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome
- Interventions
- AMG 330
- First posted
- 2015-08-11
- Last updated
- 2024-07-31
- Other registries' IDs
- eudract:2014-004462-20
- Results first posted
- 2024-07-31
- Limitations and caveats
- Group 5 dose-escalation cohort and dose-expansion cohorts were not enrolled in the study, due to the study terminating early.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Day 1 to Day 14 | DLT-evaluable Analysis Set: All DLT-evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Percentage of participants | NUMBER | |
| 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 | Percentage of participants | NUMBER | |
| SECONDARY | Response Rate in Participants With MDS | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Percentage of participants | NUMBER | |
| SECONDARY | Duration of Response | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Per the Statistical Analysis Plan, duration of response was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion. | ||
| SECONDARY | Time to Response | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Per the Statistical Analysis Plan, time to response was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion. | ||
| SECONDARY | Event-free Survival | From first dose of IP (Day 1) until the end of study, up to approximately 6 months | Per the Statistical Analysis Plan, event-free survival was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion. | ||
| SECONDARY | Overall Survival | Baseline until the end of study, up to approximately 6 months | Per the Statistical Analysis Plan, overall survival was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion. | ||
| 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) | Includes all participants who had analyzable samples. | hours | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group317
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 1 AMG 330 0.5 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 2 AMG 330 1.5 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 3 AMG 330 4 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 4 AMG 330 10 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 5 AMG 330 30 µg/Day | 1 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 6 AMG 330 10/30 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 7 AMG 330 10/60 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 8 AMG 330 10/120 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 9 AMG 330 10/240 µg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Group 1 - Cohort 10 AMG 330 10/480 µg/Day | 0 | Participants |
1 to 10 of 317Source ClinicalTrials.gov
See all 317 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - Cohort 1 AMG 330 0.5 µg/Day | 1 | |
| Overall Study | STARTED | Group 1 - Cohort 2 AMG 330 1.5 µg/Day | 1 | |
| Overall Study | STARTED | Group 1 - Cohort 3 AMG 330 4 µg/Day | 3 | |
| Overall Study | STARTED | Group 1 - Cohort 4 AMG 330 10 µg/Day | 3 | |
| Overall Study | STARTED | Group 1 - Cohort 5 AMG 330 30 µg/Day | 3 | |
| Overall Study | STARTED | Group 1 - Cohort 6 AMG 330 10/30 µg/Day | 3 | |
| Overall Study | STARTED | Group 1 - Cohort 7 AMG 330 10/60 µg/Day | 4 | |
| Overall Study | STARTED | Group 1 - Cohort 8 AMG 330 10/120 µg/Day | 4 | |
| Overall Study | STARTED | Group 1 - Cohort 9 AMG 330 10/240 µg/Day | 4 | |
| Overall Study | STARTED | Group 1 - Cohort 10 AMG 330 10/480 µg/Day | 3 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events11,596
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 1 AMG 330 0.5 µg/Day | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 2 AMG 330 1.5 µg/Day | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 3 AMG 330 4 µg/Day | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 4 AMG 330 10 µg/Day | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 5 AMG 330 30 µg/Day | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 6 AMG 330 10/30 µg/Day | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 7 AMG 330 10/60 µg/Day | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 8 AMG 330 10/120 µg/Day | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 9 AMG 330 10/240 µg/Day | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Cohort 10 AMG 330 10/480 µg/Day | 1 | 3 |
1 to 10 of 11,596Source ClinicalTrials.gov
See all 11,596 adverse eventsAdverse event totals78
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 - Cohort 1 AMG 330 0.5 µg/Day | 1 | 1 |
| Total, all-cause mortality | Group 1 - Cohort 2 AMG 330 1.5 µg/Day | 0 | 1 |
| Total, all-cause mortality | Group 1 - Cohort 3 AMG 330 4 µg/Day | 0 | 3 |
| Total, all-cause mortality | Group 1 - Cohort 4 AMG 330 10 µg/Day | 0 | 3 |
| Total, all-cause mortality | Group 1 - Cohort 5 AMG 330 30 µg/Day | 0 | 3 |
| Total, all-cause mortality | Group 1 - Cohort 6 AMG 330 10/30 µg/Day | 0 | 3 |
| Total, all-cause mortality | Group 1 - Cohort 7 AMG 330 10/60 µg/Day | 0 | 4 |
| Total, all-cause mortality | Group 1 - Cohort 8 AMG 330 10/120 µg/Day | 0 | 4 |
| Total, all-cause mortality | Group 1 - Cohort 9 AMG 330 10/240 µg/Day | 0 | 4 |
| Total, all-cause mortality | Group 1 - Cohort 10 AMG 330 10/480 µg/Day | 0 | 3 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02520427
GET https://conductscience.org/api/trials/v1/NCT02520427/results?page=2