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Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors


Inclusion Criteria:



- adult patients, >=18 years of age;

- advanced and/or metastatic solid tumor malignancy;

- measurable or evaluable disease;

- ECOG performance status 0 or 1.

Exclusion Criteria:

- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of
study drug;

- prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first
receipt of study drug. Dexamethasone may be allowed only as part of the supportive
care measures;

- major surgery within 28 days of first receipt of study drug.

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:

AEs, laboratory parameters.

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:

NO21321

NCT ID:

NCT00532090

Start Date:

November 2007

Completion Date:

February 2011

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Austin, Texas  78705
Hackensack, New Jersey  07601
Denver, Colorado  
Boston, Massachusetts