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Trial record 36 of 168 for:    pertuzumab

A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study

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ClinicalTrials.gov Identifier: NCT00096941
Recruitment Status : Completed
First Posted : November 18, 2004
Results First Posted : June 11, 2015
Last Update Posted : June 11, 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 Solid Cancers
Intervention Drug: Pertuzumab
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab
Hide Arm/Group Description

Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.

Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.

Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
disease progression             3
Arm/Group Title Pertuzumab
Hide Arm/Group Description

Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.

Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Safety population: Participants who received at least 1 dose of pertuzumab.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Experienced an Adverse Event
Hide Description [Not Specified]
Time Frame Baseline to the end of the study (up to 2 years, 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants
Arm/Group Title Pertuzumab
Hide Arm/Group Description:

Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.

Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
33.3
2.Secondary 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 2 years, 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Participants who received at least 1 dose of pertuzumab.
Arm/Group Title Pertuzumab
Hide Arm/Group Description:

Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.

Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
Complete response 0.0
Partial response 0.0
Stable disease 33.3
Progressive disease 33.3
Unknown 33.3
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: Participants who received at least 1 dose of pertuzumab.
 
Arm/Group Title Pertuzumab
Hide Arm/Group Description

Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.

Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.

All-Cause Mortality
Pertuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab
Affected / at Risk (%)
Total   0/3 (0.00%) 
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   1/3 (33.33%) 
Investigations   
EJECTION FRACTION DECREASED  1  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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: NCT00096941     History of Changes
Other Study ID Numbers: TOC2664g
First Submitted: November 17, 2004
First Posted: November 18, 2004
Results First Submitted: May 27, 2015
Results First Posted: June 11, 2015
Last Update Posted: June 11, 2015