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A Study of R547 in Patients With Advanced Solid Tumors.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400296
First received: November 15, 2006
Last updated: November 3, 2014
Last verified: November 2014
  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 in fusions 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 d ose, incremental dose-escalations will be allowed in subsequent cohorts of patie nts until the maximum tolerated dose is reached. The anticipated time on study t reatment 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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic and pharmacodynamic profiles of R547 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received: November 15, 2006
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014