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
|Condition or disease||Intervention/treatment||Phase|
|Solid Cancers||Drug: Pertuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated With Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
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 was supplied as a single-use liquid formulation.
- Percentage of Participants Who Experienced an Adverse Event [ Time Frame: Baseline to the end of the study (up to 2 years, 5 months) ]
- Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) [ Time Frame: Baseline to the end of the study (up to 2 years, 5 months) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096941
|Study Director:||Mika Derynck, M.D.||Genentech, Inc.|