Neoplasms, Myelogenous Leukemia, Acute Clinical Trial
Official title:
A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients With Advanced Malignancies, Including Acute Myeloid Leukemia (AML)
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.
n/a