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RO4987655

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Trials Updated: Sep 2, 2015

RO4987655 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2009

RO4987655 target and mechanism

Molecular targetMAP2K2, MAP2K1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

RO4987655 clinical trials

RO4987655 · 1 trial · 1 indication

Phase 1 1
NCT00817518A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid TumorsNeoplasms
COMPLETED145 Analytics
PHASE1COMPLETED
A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (Part 1)
Reviewed after each 4 week cycle
Tumor assessments (Part 2)
Every 8 weeks

Secondary Endpoints

Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)
Reviewed after each 4 week cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
RO4987655DRUGAdministered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

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 or other responsive tumor type (Part 2); * measurable and/or evaluable disease (Part 1); \>=1 measurable lesion (Part 2...

Countries:FranceGermanyNetherlandsSpainUnited Kingdom
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Frequently asked questions about RO4987655

What is RO4987655?

RO4987655 is an investigational small molecule developed by Roche Holding AG for the treatment of advanced solid tumors, including neoplasms. It is an oral agent that has been studied in a Phase 1 dose-escalation trial in patients with advanced solid tumors. It is not an approved therapy.

What does RO4987655 target?

RO4987655 targets MAP2K1 and MAP2K2, also known as MEK1 and MEK2. It is a small molecule inhibitor of these kinases, which sit in the MAPK signaling pathway that drives cell proliferation in many solid tumors. Inhibiting MAP2K1 and MAP2K2 is intended to block that signaling.

Who is developing RO4987655?

RO4987655 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical program for the compound, including the Phase 1 dose-escalation study in patients with advanced solid tumors.

What phase is RO4987655 in?

RO4987655 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. Only one clinical trial has been conducted, and that trial is now completed.

What clinical trials is RO4987655 in?

RO4987655 was studied in one clinical trial, NCT00817518, titled A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors. That Phase 1 trial enrolled 145 patients across France, Germany, the Netherlands, Spain, and the United Kingdom, and it is completed.

What is RO4987655 used for in neoplasms?

RO4987655 was studied for the treatment of advanced solid tumors, or neoplasms. The Phase 1 trial NCT00817518 evaluated dose escalation in adults aged 18 years and older with advanced solid tumors. The study is completed, and RO4987655 remains an investigational agent rather than an approved treatment.