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NCT03296696 · ClinicalTrials.gov registry record · Phase 1
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03296696: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT03296696 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03296696, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).
Primary Outcome
A DLT was any of the following occurring and regarded by the investigator as related to AMG 596. Hematological DLTs: absolute neutrophil count (ANC) \<0.5×10\^9/L for ≥7 days, febrile neutropenia with ANC\<0.5×10\^9/L and fever ≥38.5°C, platelets\<50×10\^9/L\>7 days or clinically significant bleeding. Non-hematological DLTs: any grade 4 non-hematological toxicity, any grade ≥3 non-hematological toxicity if nausea and vomiting, grade 3 non-hematologic toxicity lasting \>3 days despite treatment,
Interventions
- DRUG AMG 404
- DRUG AMG 596
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2021-08-28 |
| Phase | Phase 1 |
Why NCT03296696 stopped before completion
NCT03296696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which AMG 404 is the first listed.
NCT03296696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03296696 about?
NCT03296696 is a clinical study titled "Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma". This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in hu...
What is the current status of trial NCT03296696?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-04-18. Estimated completion is 2021-08-28.
What interventions are being tested in trial NCT03296696?
The interventions under investigation include: AMG 404 (DRUG), AMG 596 (DRUG).
Who is sponsoring clinical trial NCT03296696?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03296696's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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