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RO6839921

Phase 1

Neoplasms, Myelogenous Leukemia, Acute | Small molecule | Oncology |Roche Holding AG|Last Updated: May 17, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

RO6839921 · 1 trial · 1 indication

Phase 1 1
NCT02098967A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.Neoplasms, Myelogenous Leukemia, Acute
COMPLETED68 Analytics
PHASE1COMPLETED
A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.
Neoplasms, Myelogenous Leukemia, AcuteUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Approximately 1 year
Incidence of dose-limiting toxicities
Approximately 1 year

Secondary Endpoints

Plasma area under the concentration-time curve (AUC) of RO6839921.
Up to Day 22
Changes in serum macrophage inhibitory cytokine-1 (MIC-1) expression measured by enzyme-linked immunosorbent assay (ELISA)
Up to Day 22
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Acute myeloid leukemia patientsEXPERIMENTAL -
Cohort 0EXPERIMENTAL -
Solid tumor patientsEXPERIMENTAL -

Interventions

NameTypeDescription
RO6839921DRUGNon-escalating IV doses given on Days 1-5 of Cycle 1.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Cohort 0 and Arm A * Patient must have histologically or cytologically confirmed advanced cancer for which standard cures or relieving measures either do not exist, are ineffective or are not acceptable to the patient. * Measureable disease according to RECIST criteria version ...

Countries:United StatesCanada
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Frequently asked questions about RO6839921

What is RO6839921 used for?

RO6839921 is an investigational small molecule being studied for the treatment of advanced cancers, including acute myeloid leukemia. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.

What does RO6839921 target?

RO6839921 targets MDM2, a protein that regulates the tumor suppressor p53. By antagonizing MDM2, the drug aims to restore p53 activity, which may help suppress tumor growth in cancers such as acute myeloid leukemia.

Who makes RO6839921?

RO6839921 is being developed by Roche Holding AG, a biopharmaceutical company. The company is conducting clinical research on this investigational drug for oncology indications.

What phase is RO6839921 in?

RO6839921 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and pharmacokinetics in patients.

What clinical trials is RO6839921 in?

RO6839921 has been studied in a Phase 1 clinical trial with the identifier NCT02098967. This completed trial evaluated the safety and pharmacokinetics of the drug in patients with advanced cancers, including acute myeloid leukemia, and enrolled 68 participants in the United States and Canada.

Is RO6839921 the same as MDM2 antagonist?

RO6839921 is an MDM2 antagonist, meaning it is a type of drug that inhibits MDM2. It is not the same as a generic MDM2 antagonist; rather, it is a specific investigational compound being developed by Roche Holding AG.