A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors


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 progression;

- patients taking strong inhibitors and/or inducers of CYP3A4.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group 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:

NP18378

NCT ID:

NCT00400296

Start Date:

May 2005

Completion Date:

November 2008

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location
Austin, Texas  78705
Hackensack, New Jersey  07601
Denver, Colorado  
Charlotte, North Carolina