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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00400361

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

32.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: RG1507	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: RG1507 Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).

Arm

Intervention/Treatment

Experimental: 1

Drug: RG1507

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

Outcome Measures

Primary Outcome Measures

AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life [Throughout study]

Secondary Outcome Measures

Tumor response [Event driven]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Aurora	Colorado	United States	80045
2	New Brunswick	New Jersey	United States	08901
3	Houston	Texas	United States	77030

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00400361

Other Study ID Numbers:

BO19373

First Posted:

Nov 16, 2006

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016