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A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia


Inclusion Criteria:



- adult patients, >=18 years of age;

- solid tumor malignancies;

- failed prior therapies, or no standard therapy available;

- ECOG performance status of 0-2.

Exclusion Criteria:

- patients receiving any other agent or therapy to treat their malignancy;

- pre-existing gastrointestinal disorders which may interfere with absorption of drugs;

- clinically significant cardiovascular disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD and associated dose schedule

Outcome Time Frame:

Every 28 days

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21280

NCT ID:

NCT00559533

Start Date:

December 2007

Completion Date:

November 2012

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Albany, New York  12208
Austin, Texas  78705
Denver, Colorado  
Boston, Massachusetts