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RO5323441+ bevacizumab

Phase 1

Glioblastoma Multiforme | 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

RandomizedCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

RO5323441+ bevacizumab · 1 trial · 1 indication

Phase 1 1
NCT01308684A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent GlioblastomaGlioblastoma Multiforme
COMPLETED22 Analytics
PHASE1COMPLETED
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma
Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose-Finding Part: Dose limiting toxicity
Day 28
Efficacy-Finding part: Progression-free survival
From baseline to disease progression or death (>12 months)

Secondary Endpoints

Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
From baseline to disease progression or death (>12 months)
Dose-Finding part: Safety (incidence of adverse events)
From baseline to disease progression or death (>12 months)
Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria
From baseline to disease progression or death (>12 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
RO5323441 + bevacizumab [Avastin]DRUGDose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks
bevacizumab [Avastin]DRUGEfficacy-Finding part: 10 mg/kg intravenously once every two weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Adult patients, \>/=18 years of age * Histologically confirmed glioblastoma * Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy * Availability of at least 1 formalin-fixed paraffin-embedded tumor t...

Countries:DenmarkFranceSwitzerlandUnited Kingdom
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Frequently asked questions about RO5323441+ bevacizumab

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.