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RO5126766

Phase 1

Neoplasms | 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

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

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.
NeoplasmsUnlock trial analytics

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 RO5126766

What is RO5126766 used for?

RO5126766 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 currently in Phase 1 clinical development for oncology indications.

Who makes RO5126766?

RO5126766 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker RHHBY on the OTC market.

What phase is RO5126766 in?

RO5126766 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 dose-escalation study has been completed.

What clinical trials is RO5126766 in?

RO5126766 has been studied in one clinical trial, NCT00773526, titled 'A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.' This was a Phase 1, uncontrolled study that enrolled 52 participants with neoplasms in France, Spain, and the United Kingdom.

Is RO5126766 the same as other drugs?

RO5126766 is also known by the name RO5126766, and no alternative names have been established in public clinical trial records. It is a distinct small molecule being investigated for its potential in oncology.