Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Wichita, Kansas


Purpose:

The experimental drug CNTO 888 is currently being studied in cancer patients with solid tumors and this study is the first to use this drug for patients with idiopathic pulmonary fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effects (good and bad) on patients with IPF. The study will be conducted at approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF while enrolled in the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.


Study summary:

This study tests the safety and effectiveness of an experimental drug, CNTO 888, compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effects on patients with idiopathic pulmonary fibrosis (IPF). CNTO 888 has not been approved by any regulatory authority for use in patients with any condition. The screening phase of the study, where the study doctor will determine if a patient is eligible for the study will last for 1 to 4 weeks. The study will enroll and treat the first 20 patients as part of a safety evaluation, at selected sites. The patients will be randomized to placebo or 1 mg/kg or 5 mg/kg or 15 mg/kg CNTO 888. The study drug will be given through a needle inserted into the patient's vein (IV). A Data Monitoring Committee will be responsible to review this portion of the study, and the study in general. They will review all of the information from patients in this portion of the study, after patients have received three infusions of study agent, or 3 months have passed since the first patient was enrolled. After their review, they will recommend whether to continue enrolling additional patients for the remainder of the study, or require some modification to the study. Patients will receive study agent until Week 48 and will continue to be followed through Week 72 for assessment of safety and any other effects after discontinuation of therapy. Patients will be in the study for about 74 weeks. The end of the study is defined as the last visit of the last patient. Patients will be randomly assigned to 1 of 4 treatment groups. Group 1, placebo IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 2, CNTO 888 1 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 3, CNTO 888 5 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 4, CNTO 888 15 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Enrollment completed as planned. Dosing terminated after interim DMC (Data Monitoring Committee) review. Subjects followed until trial completed.


Criteria:

Inclusion Criteria: - Forced Vital Capacity (FVC) >= (greater than or equal to) 50% of the predicted value at screening - Abnormal lung function test results that include evidence of restriction and impaired gas exchange, or evidence of desaturation at rest or exercise or decreased diffusing capacity of the lung for carbon monoxide (DLCO) - Bibasilar reticular abnormalities with minimal ground-glass opacities on high-resolution computed tomography (HRCT) scans - Have surgical lung biopsy evidence of usual interstitial pneumonia (UIP) and/or HRCT scan-based diagnosis of IPF - Relative decrease of >= 10% in forced vital capacity (FVC), or relative decrease of >= 15% in DLCO, or evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities), or significant worsening of dyspnea at rest or with exertion. Exclusion Criteria: - Have evidence of interstitial pneumonia other than IPF - Diagnosis of IPF is not confirmed by HRCT or lung biopsy results - Partial pressure of oxygen in arterial blood (PaO2) < 55 mmHg (sea level) or 50 mmHg (altitude) at rest on room air - Have a diagnosis of other significant respiratory disorder (eg, asthma, tuberculosis (TB), sarcoidosis, aspergillosis, chronic obstructive pulmonary disease [COPD], or cystic fibrosis) - Have obstruction on prebronchodilator pulmonary function tests (PFTs) (defined as FEV1/FVC < 0.7) at screening or demonstrate an increase in FEV1 >= 12% postbronchodilator.


Study is Available At:


Original ID:

CR015235


NCT ID:

NCT00786201


Secondary ID:

CNTO888PUL2001


Study Acronym:


Brief Title:

A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)


Official Title:

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects With Idiopathic Pulmonary Fibrosis


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Centocor, Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • Germany: Ethics Commission
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:

Actual


Overall Contact Information

Official Name:Centocor, Inc. Clinical Trial
Study Director
Centocor, Inc.

Study Dates

Start Date:December 2008
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:December 2012
Last Changed Date:December 28, 2012
First Received Date:November 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in subjects with IPF.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effect of CNTO 888 on measures of disease progression, patient reported outcomes, functional capacity and health-related quality of life, and to assess the pharmacokinetics and pharmacodynamics of CNTO 888 in subjects with IPF.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48
Arm Name:Placebo
Intervention Type:Drug
Name:CNTO 888 1 mg/kg
Description:IV infusion every 4 weeks, from Week 0 through Week 48
Arm Name:CNTO 888 1 mg/kg
Intervention Type:Drug
Name:CNTO 888 5 mg/kg
Description:IV infusion every 4 weeks, from Week 0 through Week 48
Arm Name:CNTO 888 5 mg/kg
Intervention Type:Drug
Name:CNTO 888 15 mg/kg
Description:IV infusion every 4 weeks, from Week 0 through Week 48
Arm Name:CNTO 888 15 mg/kg

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:CNTO 888 1 mg/kg
Study Arm Type:Experimental
Arm Name:CNTO 888 5 mg/kg
Study Arm Type:Experimental
Arm Name:CNTO 888 15 mg/kg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Centocor, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.