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R306465

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Apr 27, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

R306465 · 1 trial · 1 indication

Phase 1 1
NCT00677001A Research Study to Evaluate the Safety of R306465, a Drug in Development for Cancer and to Study the Absorption, Break Down and Elimination in Patients With Advanced Solid Malignancies.Neoplasms
COMPLETED15 Analytics
PHASE1COMPLETED
A Research Study to Evaluate the Safety of R306465, a Drug in Development for Cancer and to Study the Absorption, Break Down and Elimination in Patients With Advanced Solid Malignancies.
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Study Endpoints

Primary Endpoints

Determine the safety and maximum tolerated dose of R306465 when given as a daily oral dose during 3 weeks followed by a 1 week recovery period. Study the absorption, break down and elimination of R306465 following oral administration.

Secondary Endpoints

Investigate the effect of food on oral administration of R306465. Evaluate the antitumor activity of R306465 in patients with measurable cancer.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
R306465DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Confirmed solid malignancy that is metastatic or unresectable, and for which standard curative or palliative measures does not exist or are no longer effective * Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2 * Life expectancy \> 3 mo...

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Frequently asked questions about R306465

What is R306465 used for?

R306465 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be cancerous. It was evaluated in patients with advanced solid malignancies to assess its safety and how the body absorbs, breaks down, and eliminates the drug.

Who makes R306465?

R306465 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational small molecule in the oncology therapeutic area, studied for its potential use in treating neoplasms.

What phase is R306465 in?

R306465 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and pharmacological properties in patients with advanced solid malignancies.

What clinical trials is R306465 in?

R306465 has one completed clinical trial registered as NCT00677001. This Phase 1 study evaluated the safety of R306465 and studied its absorption, breakdown, and elimination in 15 patients with advanced solid malignancies. The trial was uncontrolled and not randomized or double-blinded.

Is R306465 the same as any other drug?

No alternative names for R306465 have been identified. The drug is known by its code name R306465 and is being developed by Johnson & Johnson as an investigational small molecule for the treatment of neoplasms.