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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 15, 2006

Last Updated Date

April 15, 2009

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00400361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Tumor response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Neoplasms

Intervention ^†

Drug: R1507

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

June 2009

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400361

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.