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

This study is ongoing, but not recruiting participants.

First Received: November 15, 2006 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00400361

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: R1507	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	93
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: R1507 Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400361

Locations

United States, Colorado

AURORA, Colorado, United States, 80010
United States, New Jersey

NEW BRUNSWICK, New Jersey, United States, 08901
United States, Texas

HOUSTON, Texas, United States, 77030

SAN ANTONIO, Texas, United States, 78229

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO19373
Study First Received:	November 15, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00400361 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009