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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 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. The trial reports 5 study locations across 5 states.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02098967
The ClinicalTrials.gov registry entry for NCT02098967 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.
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