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"An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

"An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."


Inclusion Criteria:



- adult patients, >=18 years of age;

- cancer not amenable to curative treatment (ie advanced and/or metastatic);

- measurable or evaluable disease;

- adequate cardiac, hepatic and renal function.

Exclusion Criteria:

- patients with known CNS metastases;

- serious cardiovascular illness or other medical conditions;

- prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of
treatment , or hormone therapy within 14 days of start of treatment;

- inability to swallow oral medications, or impaired gastrointestinal absorption.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

Throughout study

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:

NO18674

NCT ID:

NCT00493155

Start Date:

October 2005

Completion Date:

February 2009

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Austin, Texas  78705
Flint, Michigan  48532
Boston, Massachusetts  
Las Vegas, Nevada  89109