Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 168 for:    pertuzumab

Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00063154
Recruitment Status : Completed
First Posted : June 25, 2003
Results First Posted : June 8, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: Pertuzumab
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab
Hide Arm/Group Description Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Period Title: Overall Study
Started 51
Completed 0
Not Completed 51
Reason Not Completed
Disease progression             27
Adverse Event             2
Physician Decision             10
Death             3
Reason unspecified             1
Did not receive treatment             8
Arm/Group Title Pertuzumab
Hide Arm/Group Description Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
Safety population: All participants who received any amount of pertuzumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
62.5  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
17
  39.5%
Male
26
  60.5%
1.Primary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Hide Description A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
Complete response 0.0
Partial response 0.0
Stable disease 51.4
Progressive disease 48.6
2.Secondary Outcome
Title Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Hide Description A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
Complete response pHER2+ (n=4) 0
Partial response pHER2+ (n=4) 0
Stable disease pHER2+ (n=4) 2
Progressive disease pHER2+ (n=4) 1
No tumor assessment pHER2+ (n=4) 1
Unable to evaluate response pHER2+ (n=4) 0
Complete response pHER2- (n=34) 0
Partial response pHER2- (n=34) 0
Stable disease pHER2- (n=34) 15
Progressive disease pHER2- (n=34) 13
No tumor assessment pHER2- (n=34) 5
Unable to evaluate response pHER2- (n=34) 1
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: weeks
6.6
(6.0 to 14.7)
4.Secondary Outcome
Title Number of Participants Free From Disease Progression at 3, 6, and 12 Months
Hide Description Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
3 months 8
6 months 1
9 months 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All participants who received any amount of pertuzumab.
 
Arm/Group Title Pertuzumab
Hide Arm/Group Description Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
All-Cause Mortality
Pertuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab
Affected / at Risk (%)
Total   15/43 (34.88%) 
Cardiac disorders   
PERICARDIAL EFFUSION  1  1/43 (2.33%) 
Gastrointestinal disorders   
NAUSEA  1  1/43 (2.33%) 
General disorders   
PAIN  1  1/43 (2.33%) 
Immune system disorders   
HYPERSENSITIVITY  1  1/43 (2.33%) 
Infections and infestations   
PNEUMONIA  1  7/43 (16.28%) 
CELLULITIS  1  1/43 (2.33%) 
SEPSIS  1  1/43 (2.33%) 
Metabolism and nutrition disorders   
HYPERCALCAEMIA  1  1/43 (2.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
NON−SMALL CELL LUNG CANCER  1  1/43 (2.33%) 
Nervous system disorders   
SPINAL CORD COMPRESSION  1  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/43 (2.33%) 
DYSPNOEA  1  1/43 (2.33%) 
HYPOXIA  1  1/43 (2.33%) 
PLEURAL EFFUSION  1  1/43 (2.33%) 
PULMONARY EMBOLISM  1  1/43 (2.33%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/43 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab
Affected / at Risk (%)
Total   42/43 (97.67%) 
Blood and lymphatic system disorders   
ANAEMIA  1  3/43 (6.98%) 
Gastrointestinal disorders   
DIARRHOEA  1  15/43 (34.88%) 
NAUSEA  1  8/43 (18.60%) 
VOMITING  1  5/43 (11.63%) 
CONSTIPATION  1  4/43 (9.30%) 
STOMATITIS  1  4/43 (9.30%) 
General disorders   
FATIGUE  1  16/43 (37.21%) 
PAIN  1  6/43 (13.95%) 
PYREXIA  1  4/43 (9.30%) 
ASTHENIA  1  3/43 (6.98%) 
CHILLS  1  3/43 (6.98%) 
OEDEMA PERIPHERAL  1  3/43 (6.98%) 
Investigations   
EJECTION FRACTION DECREASED  1  3/43 (6.98%) 
Metabolism and nutrition disorders   
ANOREXIA  1  8/43 (18.60%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  5/43 (11.63%) 
BACK PAIN  1  4/43 (9.30%) 
MYALGIA  1  3/43 (6.98%) 
Nervous system disorders   
HEADACHE  1  5/43 (11.63%) 
DIZZINESS  1  3/43 (6.98%) 
Psychiatric disorders   
ANXIETY  1  6/43 (13.95%) 
INSOMNIA  1  3/43 (6.98%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  6/43 (13.95%) 
DYSPNOEA  1  6/43 (13.95%) 
HAEMOPTYSIS  1  3/43 (6.98%) 
Skin and subcutaneous tissue disorders   
RASH  1  5/43 (11.63%) 
NAIL DISORDER  1  3/43 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00063154     History of Changes
Obsolete Identifiers: NCT00095602
Other Study ID Numbers: TOC2572g
First Submitted: June 20, 2003
First Posted: June 25, 2003
Results First Submitted: May 26, 2015
Results First Posted: June 8, 2015
Last Update Posted: July 7, 2015