NCT01204996

Brief Summary

The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1 cancer

Geographic Reach
2 countries

5 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

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

First QC Date

September 16, 2010

Last Update Submit

May 29, 2012

Conditions

Cancer

Keywords

monoclonal antibodysolid tumorchemotherapystandard of care

Outcome Measures

Primary Outcomes (1)

  • The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.

    During treatment and up to 30 days after last study treatment

Secondary Outcomes (2)

  • Pharmacokinetics(rate of movement in the body and then the clearance)

    during study as specified in the protocol (interim analysis) and at End of Study (1 year)

  • Pharmacodynamics (action of drug on body systems)

    during study as specified in the protocol (interim analysis) and at End of Study (1 year)

Study Arms (4)

1

EXPERIMENTAL

CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

Drug: CNTO888 + docetaxel

2

EXPERIMENTAL

CNTO888 + gemcitabine 15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle

Drug: CNTO888 + gemcitabine

3

EXPERIMENTAL

CNTO888 + Paclitaxel and carboplatin 15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks

Drug: CNTO888 + Paclitaxel and carboplatin

4

EXPERIMENTAL

CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection 10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks

Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection

Interventions

CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injectionDRUG

10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks

4
CNTO888 + gemcitabineDRUG

15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle

2
CNTO888 + Paclitaxel and carboplatinDRUG

15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks

3
CNTO888 + docetaxelDRUG

15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

1

Eligibility Criteria

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

You may qualify if:

  • Documentation of an advanced solid tumor
  • No more than 2 previous anticancer therapies
  • good performance status
  • adequate bone marrow, liver, and renal function / adequate blood test values
  • willing to use birth control measures

You may not qualify if:

  • No residual toxicities resulting from previous therapy
  • no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
  • clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

PAU de Sanchinarro, Spain

Location

Related Publications (1)

  • Brana I, Calles A, LoRusso PM, Yee LK, Puchalski TA, Seetharam S, Zhong B, de Boer CJ, Tabernero J, Calvo E. Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study. Target Oncol. 2015 Mar;10(1):111-23. doi: 10.1007/s11523-014-0320-2. Epub 2014 Jun 15.

    PMID: 24928772DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

carlumabGemcitabinePaclitaxelCarboplatinDocetaxel

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

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

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 20, 2010

Study Start

May 1, 2010

Study Completion

November 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(2)ES(3)