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RG547

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

UNCONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

RG547 · 1 trial · 1 indication

Phase 1 1
NCT00400296A Study of R547 in Patients With Advanced Solid Tumors.Neoplasms
COMPLETED58 Analytics
PHASE1COMPLETED
A Study of R547 in Patients With Advanced Solid Tumors.
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

AEs, laboratory parameters.
Throughout study

Secondary Endpoints

Pharmacokinetic and pharmacodynamic profiles of R547
Throughout study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
RG547DRUGAdministered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
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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; * locally advanced or metastatic solid tumors; * measurable or evaluable disease. Exclusion Criteria: * prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study; * prior history of CNS metastases with disease prog...

Countries:United States
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Frequently asked questions about RG547

What is RG547 used for?

RG547 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 as a potential oncology therapy for patients with advanced solid tumors.

Who makes RG547?

RG547 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is RG547 in?

RG547 is in Phase 1 clinical development. It has completed a Phase 1 trial, meaning it is still in the early stages of clinical investigation. As an investigational drug, it has not yet been approved by regulatory authorities and remains under study to assess its safety and potential benefits.

What clinical trials is RG547 in?

RG547 has one completed clinical trial registered under NCT00400296, titled "A Study of R547 in Patients With Advanced Solid Tumors." This Phase 1 study enrolled 58 participants in the United States and evaluated the drug in patients with neoplasms, with no control group.

Is RG547 FDA approved?

RG547 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received marketing authorization from the U.S. Food and Drug Administration or any other regulatory agency. The drug remains in clinical development and is not available for commercial use.