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NCT04727554 · ClinicalTrials.gov registry record · Phase 1
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 17
- Study locations
NCT04727554: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Amgen.
NCT04727554 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Amgen. The registered enrollment target is 11 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (94% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04727554, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.
Primary Outcome
DLTs were defined as: * Grade 5 events * Grade 4 neutropenia/thrombocytopenia of any duration * Grade 3 thrombocytopenia w/ clin significant bleeding or lasting \>7 days * Febrile neutropenia * Grade 4 anemia * Grade 3/4 non-hematologic toxicity, except: Grade 3 nausea/vomiting or diarrhea \< 72 hours; Grade 3 fatigue \< 1 week; Asymptomatic grade 3 electrolyte abnormalities that last \< 72 hours, are not clinically complicated, and resolve spontaneously or respond to conventional medical inter
Conditions Studied
Interventions
- DRUG AMG 994
- DRUG AMG 404
Study Locations (17)
Other
- Universitair Ziekenhuis Gent - Ghent
- Centre Leon Berard - Lyon
- Universitatsklinikum Ulm - Ulm
- Universitätsklinikum Würzburg - Würzburg
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy - Warsaw
- University College London Hospital - London
California
- City of Hope National Medical Center - Duarte
Michigan
- Henry Ford Hospital, Henry Ford Health Systems - Detroit
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Victoria
- Monash Medical Centre - Clayton
Western Australia
- Linear Clinical Research Limited - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2023-06-05 |
| Phase | Phase 1 |
What the finished NCT04727554 record still lists
NCT04727554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which AMG 994 is the first listed.
NCT04727554 lists 17 locations in 12 states (Other, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT04727554 about?
NCT04727554 is a clinical study titled "Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors". The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.
What is the current status of trial NCT04727554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-04-29. Estimated completion is 2023-06-05.
What conditions does trial NCT04727554 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT04727554?
The interventions under investigation include: AMG 994 (DRUG), AMG 404 (DRUG).
Who is sponsoring clinical trial NCT04727554?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04727554 being conducted?
This trial has 17 study locations across California, Michigan, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04727554's enrollment target sits among peer trials
11 139th of 144 higher than 6 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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