NCT00265135

Brief Summary

The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2003

Typical duration for phase_1

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

2.5 years

First QC Date

December 13, 2005

Last Update Submit

July 1, 2014

Conditions

Carcinoma, Renal Cell

Keywords

Renal cell carcinomaCNTO 328InfusionsRenal cell cancer

Outcome Measures

Primary Outcomes (6)

  • Number of Patients With Dose-limiting Toxicity as a Measure of Safety (Parts 1 and 3)

    Up to 6 weeks after the last dose

  • Number of Patients With Tumor Response (Parts 2 and 3)

    Tumor response will be evaluated as sum of complete response (CR) and partial response (PR). CR is disappearance of all measurable and evaluable disease. No new lesions. No evidence of non evaluable disease. PR is 50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.

    Up to Week 11

  • Serum Concentration of CNTO 328 (Parts 1, 2, and 3)

    Pre dose, up to 6 weeks after the last dose

  • Number of Participants With Adverse Events (Parts 1, 2, and 3)

    Up to 6 weeks after the last dose

  • Change From Baseline in C-reactive Protein (Part 1)

    Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)

  • Change From Baseline in Interleukin-6 levels (Part 1)

    Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)

Secondary Outcomes (8)

  • Serum Antibodies to CNTO 328 (Parts 1, 2, and 3)

    Up to 6 weeks after the last dose

  • Number of Patients With Clinical Benefit (Parts 1, 2, and 3)

    Up to 6 weeks after the last dose

  • Time to disease progression (Parts 2 and 3)

    Up to 6 weeks after the last dose

  • Duration of Tumor Response (Parts 2 and 3)

    Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose

  • Number of Patients With an Overall Tumor Response (Parts 2 and 3)

    Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose

  • +3 more secondary outcomes

Study Arms (3)

Part 1 (CNTO 328)

EXPERIMENTAL

In Part 1 of the study, 4 intravenous infusions (IV) \[injection of a substance into a vein\] of CNTO 328 will be administered to patients in 4 dose levels ranging from 1, 3, 6, and 12 mg/kg on days 1, 29, 43, and 57 to determine the maximum tolerated dose for Part 2 of the study.

Drug: CNTO 328

Part 2 (CNTO 328)

EXPERIMENTAL

In Part 2 of the study, 2 well tolerated dose levels of CNTO 328 from Part 1 of the study will be administered every 3 weeks as 4 IV infusions to patients.

Drug: CNTO 328

Part 3 (CNTO 328)

EXPERIMENTAL

In Part 3 of the study, CNTO 328 at a dose level of 6 mg/kg will be administered as IV infusion every 2 weeks for at least 6 doses.

Drug: CNTO 328

Interventions

CNTO 328DRUG

Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.

Part 1 (CNTO 328)Part 2 (CNTO 328)Part 3 (CNTO 328)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis (histologically confirmed, preferably) of metastatic renal cell carcinoma with documented metastases beyond the level of the regional lymphatics (ie, any T, any N, M1 disease)
  • Measurable or evaluable disease (Part 1); measurable disease (Part 2 and Part 3)
  • Documented disease progression based on objective tumor assessment (Part 2 and Part 3), proven by tumor measurements on 2 computerized tomography scans within 6 months prior to enrollment
  • Life expectancy greater than or equal to 6 months at screening
  • Serum C-reactive protein (CRP): detectable ( 4 mg/L or more) according to the standard assay of the core laboratory (Part 1 and Part 2); serum CRP detectable to 30 mg/L or more (Part 3)

You may not qualify if:

  • Received any investigational drug within 30 days, whichever is longer
  • History of receiving murine or chimeric proteins or human/murine recombination products (such as BE8 and other anti-IL-6 monoclonal antibodies)
  • Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure
  • Chronic infection, prior history of recurrent infection, or clinically important active infection
  • Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or peripheral blood stem cell transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Hradec nad Svitavou, Czechia

Location

Unknown Facility

Caen, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Montpellier Cedex 5 N/A, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

siltuximab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

August 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

FR(5)CZ(2)GB(4)NL(3)