NCT00992186

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
4 countries

13 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

September 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 20, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

September 29, 2009

Results QC Date

March 29, 2013

Last Update Submit

June 18, 2013

Conditions

Prostate Cancer

Keywords

Prostate cancerInfusionCarlumabCNTO 888

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Composite Response

    The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.

    Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab

Secondary Outcomes (12)

  • Percentage of Participants With Objective Tumor Response

    Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab

  • Progression-Free Survival (PFS)

    Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab

  • Overall Survival (OS)

    Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab

  • Percentage of Participants With Prostate Specific Antigen (PSA) Response

    Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab

  • Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response

    Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab

  • +7 more secondary outcomes

Other Outcomes (1)

  • Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score

    Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab

Study Arms (1)

Carlumab

EXPERIMENTAL
Drug: Carlumab

Interventions

CarlumabDRUG

Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.

Carlumab

Eligibility Criteria

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

You may qualify if:

  • Histological documentation of adenocarcinoma of the prostate
  • Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
  • Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
  • Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
  • At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent

You may not qualify if:

  • Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
  • Known or symptomatic Central Nervous System metastases
  • Residual toxicities resulting from previous therapy that are Grade 2 or more (except for alopecia)
  • Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
  • Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Orange City, Florida, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Guildford, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

carlumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Senior Director, Early Clinical Development Global Leader
Organization
Centocor Research & Development, Inc., PA, USA
+1-908-927-3159

Study Officials

  • Centocor Research & Development, Inc., PA, USA Clinical Trial

    Centocor Research & Development, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 9, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 24, 2013

Results First Posted

May 20, 2013

Record last verified: 2013-06

Locations

BE(3)US(3)RU(2)GB(5)