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A Study of R547 in Patients With Advanced Solid Tumors.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400296
First Posted: November 16, 2006
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

Condition Intervention Phase
Neoplasms Drug: RG547 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Pharmacokinetic and pharmacodynamic profiles of R547 [ Time Frame: Throughout study ]

Enrollment: 58
Study Start Date: May 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG547
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400296


Locations
United States, Colorado
Aurora, Colorado, United States, 80045
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Charlotte, North Carolina, United States, 28203
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00400296     History of Changes
Other Study ID Numbers: NP18378
First Submitted: November 15, 2006
First Posted: November 16, 2006
Last Update Posted: November 2, 2016
Last Verified: November 2016