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RO4987655

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

RO4987655 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed by Roche Holding AG for use in oncology, specifically in patients with advanced solid tumors.

Who makes RO4987655?

RO4987655 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The drug is currently in clinical development for the treatment of neoplasms, including advanced solid tumors.

What phase is RO4987655 in?

RO4987655 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and tolerability in patients with advanced solid tumors, and it remains in the early stages of clinical testing.

What clinical trials is RO4987655 in?

RO4987655 has been studied in one clinical trial, identified as NCT00817518. This was a dose-escalating study in patients with advanced solid tumors. The trial enrolled 145 participants and was conducted in France, Germany, Netherlands, Spain, and the United Kingdom. The study has been completed.

Is RO4987655 the same as any other drug?

RO4987655 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Roche Holding AG and is currently in Phase 1 clinical trials for the treatment of neoplasms, specifically advanced solid tumors.