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Sponsored by: |
Hoffmann-La Roche |
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00400361 |
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. 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: R1507 |
Phase I |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Dose-Escalation Study of R1507 in Patients With Advanced Solid Tumors. |
Estimated Enrollment: | 93 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
1: Experimental |
Drug: R1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
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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:
Contact: Please reference Study ID Number: PDO_BO19373 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
United States, Colorado | |||||
Recruiting | |||||
AURORA, Colorado, United States, 80010 | |||||
United States, New Jersey | |||||
Active, not recruiting | |||||
NEW BRUNSWICK, New Jersey, United States, 08901 | |||||
United States, Texas | |||||
Recruiting | |||||
HOUSTON, Texas, United States, 77030 | |||||
Recruiting | |||||
SAN ANTONIO, Texas, United States, 78229 |
Hoffmann-La Roche |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BO19373 |
First Received: | November 15, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00400361 |
Health Authority: | United States: Food and Drug Administration |
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