A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00400361

Run by

Hoffmann-La Roche

People needed

98

Starts

2006-04-01

Expected to finish

2011-04-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• severe, uncontrolled systemic disease;
• patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
• patients with diabetes mellitus.

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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