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Avutometinib (RO5126766)

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Target and mechanism

Molecular targetMAP2K1, MAP2K2
Target classInhibitor
ModalitySmall molecule

Also known as RO5126766

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Avutometinib (RO5126766) · 1 trial · 1 indication

Phase 1 1
NCT00773526A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.Neoplasms
COMPLETED52 Analytics
PHASE1COMPLETED
A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
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Study Endpoints

Primary Endpoints

Maximum tolerated dose (Part 1)
Throughout study
Tumor assessments (Part 2)
Event driven

Secondary Endpoints

AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
RO5126766DRUGAdministered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * adult patients, \>=18 years of age; * advanced and/or metastatic cancer not amenable to standard therapy; * any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2); * measurable and/or evaluable disease (Part 1), \>=1 measura...

Countries:FranceSpainUnited Kingdom
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Frequently asked questions about Avutometinib (RO5126766)

What is Avutometinib (RO5126766)?

Avutometinib, also known as RO5126766, is an investigational small molecule developed by Roche Holding AG (ticker RHHBY) for the treatment of neoplasms, or advanced solid tumors. It is being studied in oncology and has completed a Phase 1 dose-escalation trial. It is not yet approved for any indication.

What does Avutometinib (RO5126766) target?

Avutometinib targets MAP2K1 and MAP2K2, also known as MEK1 and MEK2. It is a small molecule inhibitor of these kinases, which are components of the MAP kinase signaling pathway that is frequently dysregulated in cancer. By inhibiting MAP2K1 and MAP2K2, the drug aims to block tumor cell proliferation.

Who is developing Avutometinib (RO5126766)?

Avutometinib is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in patients with advanced solid tumors.

What phase is Avutometinib (RO5126766) in?

Avutometinib is in Phase 1 clinical development. It has completed one Phase 1 dose-escalation trial in patients with advanced solid tumors. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.

What clinical trials is Avutometinib (RO5126766) in?

Avutometinib has been studied in the Phase 1 trial NCT00773526, titled A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors. This completed trial enrolled 52 patients across France, Spain, and the United Kingdom. It was an uncontrolled, non-double-blind study in adults with neoplasms.

Is Avutometinib the same as RO5126766?

Yes, Avutometinib and RO5126766 refer to the same investigational drug. RO5126766 is an alternative name or code used by the developer, Roche Holding AG. Both names identify the same small molecule inhibitor targeting MAP2K1 and MAP2K2.