Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02098967
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2014-03-25
Brief Title:
A Study of the Safety and Pharmacokinetics of RO6839921 An MDM2 Antagonist in Patients With Advanced Cancers Including Acute Myeloid Leukemia
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relapsedrefractory 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 progressionrelapse or unacceptable toxicity
In arm A RO6839921 will be given to patients with advanced solid tumor malignancies In Arm B RO6839921 will be given to patients with relapsedrefractory 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 progressionrelapse or unacceptable toxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RG7775 | OTHER | Roche | None |