A Multiple Ascending Dose 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RG1507

Drug

Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).

Primary outcomes

AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life

Time frame: Throughout study

Secondary outcomes

Tumor response

Time frame: Event driven

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Nov 16, 2006
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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