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NCT02098967 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.
A Phase 1 study of Neoplasms, Myelogenous Leukemia, Acute, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 5
- Study locations
NCT02098967: Completed Phase 1 study of Neoplasms, Myelogenous Leukemia, Acute, sponsored by Hoffmann-La Roche.
NCT02098967 is a Phase 1 study of Neoplasms, Myelogenous Leukemia, Acute that has completed, run by Hoffmann-La Roche. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098967, a Phase 1 study of Neoplasms, Myelogenous Leukemia, Acute, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 5
- Study locations
Study Summary
This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior to investigations in either arm, patients in a single cohort, Cohort 0, will receive non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle. Interim PK and safety data from this cohort will be evaluated before initiating dose-escalation. In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia (AML). The arms will escalate independently. Escalation will begin in solid tumor patients (Arm A) in single patient cohorts, using a new Continual Reassessment Method (n-CRM). Escalation for AML patients will be initiated at or below the dose level that causes \>/= Grade 2 hematologic side effects in Arm A. Escalation in AML patients will follow a rolling 6 design. In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles. There will be no intrapatient dose escalation. All patients may be treated until disease progression/relapse or unacceptable toxicity.
Conditions Studied
Interventions
- DRUG RO6839921
Study Locations (5)
Colorado
- University of Colorado - Aurora
Missouri
- Washington University - St Louis
South Carolina
- Medical University of South Carolina; Hollings Cancer Center - Charleston
Ontario
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept - Toronto
Quebec
- Jewish General Hospital / McGill University - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-04-21 |
| Est. Completion | 2018-05-07 |
| Phase | Phase 1 |
What the finished NCT02098967 record still lists
NCT02098967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Neoplasms, Myelogenous Leukemia, Acute appearing as the primary indexed condition, and to 1 intervention - of which RO6839921 is the first listed.
NCT02098967 lists 5 locations in 5 states (Colorado, Missouri, South Carolina).
Frequently Asked Questions
What is clinical trial NCT02098967 about?
NCT02098967 is a clinical study titled "A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.". This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior to investigations in either arm, patients in a single cohort, Cohort 0, will receive non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle. Interim PK and safety data from th...
What is the current status of trial NCT02098967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2014-04-21. Estimated completion is 2018-05-07.
What conditions does trial NCT02098967 study?
This clinical trial studies the following conditions: Neoplasms, Myelogenous Leukemia, Acute.
What interventions are being tested in trial NCT02098967?
The interventions under investigation include: RO6839921 (DRUG).
Who is sponsoring clinical trial NCT02098967?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02098967 being conducted?
This trial has 5 study locations across Colorado, Missouri, South Carolina, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02098967's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 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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