Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGRG1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response | Event driven |
Countries
United States
Outcome results
None listed