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RO5323441

Phase 1

Carcinoma, Hepatocellular | 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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

RO5323441 · 2 trials · 2 indications

Phase 1 2
NCT01308723A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular CarcinomaCarcinoma, Hepatocellular
COMPLETED6 Analytics
NCT01148758A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian CancerColorectal Cancer, Ovarian Cancer
COMPLETED7 Analytics
PHASE1COMPLETED
A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma
Carcinoma, HepatocellularUnlock trial analytics
PHASE1COMPLETED
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
Colorectal Cancer, Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part I : Safety/dose-limiting toxicity: Incidence of adverse events
up to 12 months
Part I: Determination of recommended Part II dose
up to 12 months
Part II: Safety/tolerability: Incidence of adverse events
up to 28 months
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
up to 19.5 months

Secondary Endpoints

Pharmacokinetics of RO5323441 in combination with sorafenib
up to 40 months
Pharmacokinetics of sorafenib in combination with RO5323441
up to 12 months
Pharmacodynamic biomarkers (DCE-Magnetic Resonance Imaging evaluations, Placental Growth Factor, Vascular Endothelial Growth Factor Receptors)
up to 40 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part IEXPERIMENTAL -
Part II (A)EXPERIMENTAL -
Part II (B)ACTIVE_COMPARATOR -
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
RO5323441DRUGescalating doses iv
sorafenibDRUG400 mg orally twice daily to once every other day
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adult patients \>/= 21 years of age * Advanced or metastatic and/or unresectable hepatocellular carcinoma * At least 1 measurable lesion according to RECIST criteria * Primary tumor in situ (Expansion Cohort Part I, Part II) * Eastern Cooperative Oncology Group (ECOG) performa...

Countries:SingaporeBelgiumSpainUnited Kingdom
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Frequently asked questions about RO5323441

What is RO5323441 used for?

RO5323441 is an investigational small molecule being studied for use in oncology, specifically for hepatocellular carcinoma, glioblastoma multiforme, colorectal cancer, and ovarian cancer. It has been evaluated in Phase 1 clinical trials, both as a single agent and in combination with other therapies.

Who makes RO5323441?

RO5323441 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored Phase 1 clinical trials of this investigational oncology drug.

What phase is RO5323441 in?

RO5323441 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for this asset are Phase 1 studies.

What clinical trials is RO5323441 in?

RO5323441 has been studied in three completed Phase 1 trials: NCT01148758 in metastatic treatment-refractory colorectal or ovarian cancer, NCT01308684 in recurrent glioblastoma in combination with bevacizumab, and NCT01308723 in hepatocellular carcinoma in combination with sorafenib.

Is RO5323441 the same as other drugs?

RO5323441 is an investigational small molecule developed by Roche. No alternative names for this drug have been reported in clinical trial records. It is distinct from the combination agents it has been studied with, such as bevacizumab and sorafenib.