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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00400296 |
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 |
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Neoplasms |
Drug: R547 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Enrollment: | 58 |
Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: R547
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
AURORA, Colorado, United States, 80010 | |
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NP18378 |
Study First Received: | November 15, 2006 |
Last Updated: | May 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00400296 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neoplasms |