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A Study of R547 in Patients With Advanced Solid Tumors.

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. Identifier: NCT00400296
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: RG547 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00400296

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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
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT00400296    
Other Study ID Numbers: NP18378
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016