A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | April 2006 |
| End Date: | April 2011 |
A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.
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.
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.
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.
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