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RO5045377

Phase 1

Myelogenous Leukemia, Acute | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

RO5045377 · 1 trial · 1 indication

Phase 1 1
NCT01635296A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous LeukemiaMyelogenous Leukemia, Acute
COMPLETED43 Analytics
PHASE1COMPLETED
A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Myelogenous Leukemia, AcuteUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose/dose-limiting toxicities
approximately 12 months
Safety: Incidence of adverse events
approximately 12 months

Secondary Endpoints

Efficacy: Hematologic response
approximately 1 year
Pharmacodynamics: Biomarkers (MIC-1, protein, nucleic acid, other) from bone marrow/buccal tissue/blood
Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5)
Pharmacokinetics: Cmax/area under the concentration-time curve
Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A: Previously untreatedEXPERIMENTAL -
B: Relapse/RefractoryEXPERIMENTAL -

Interventions

NameTypeDescription
RO5045377DRUGMultiple escalating oral doses, Days 1 to 10 of each 28-day cycle
cytarabineDRUG20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including: * Arm A: Patients who have not received prior standard induction chemotherapy, considered unsuitable for sta...

Countries:United StatesCanadaFranceItalyUnited Kingdom
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Frequently asked questions about RO5045377

What is RO5045377 used for?

RO5045377 is an investigational small molecule being studied for the treatment of acute myelogenous leukemia, a type of cancer that affects the blood and bone marrow. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RO5045377?

RO5045377 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY.

What phase is RO5045377 in?

RO5045377 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. A Phase 1 trial has been completed to evaluate its safety and tolerability in patients with acute myelogenous leukemia.

What clinical trials is RO5045377 in?

RO5045377 has been studied in one completed Phase 1 clinical trial, identified as NCT01635296. This trial evaluated the drug in combination with cytarabine in patients with acute myelogenous leukemia. The study enrolled 43 participants across the United States, Canada, France, Italy, and the United Kingdom.

Is RO5045377 the same as RO5045337?

RO5045377 is closely related to RO5045337, which is the compound named in the clinical trial NCT01635296. The trial title refers to RO5045337, while the drug asset is listed as RO5045377, suggesting they may be the same or highly similar investigational agents.