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

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: RG1507

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400361

BO19373

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RG1507