A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400361
First received: November 15, 2006
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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: RG1507 |
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 Dose-escalation Study of R1507 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, Cmax, Tmax, AUC, clearance, Vdss elimination half life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tumor response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
| Enrollment: | 98 |
| Study Start Date: | April 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RG1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
|
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;
- solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
- metastatic or locally advanced disease, not curable by any currently available treatment.
Exclusion Criteria:
- severe, uncontrolled systemic disease;
- patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
- patients with diabetes mellitus.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400361
Locations
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00400361 History of Changes |
| Other Study ID Numbers: | BO19373 |
| Study First Received: | November 15, 2006 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013