An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated With Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study

Genentech, Inc.0 sites3 target enrollmentMay 2005

ConditionsSolid Cancers

InterventionsPertuzumab

DrugsPertuzumab

Overview

Phase: Phase 2
Intervention: Pertuzumab
Conditions: Solid Cancers
Sponsor: Genentech, Inc.
Enrollment: 3
Primary Endpoint: Percentage of Participants Who Experienced an Adverse Event
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

October 2007

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•ECOG performance status of 0, 1, or 2
•Completion of treatment in a previous Genentech sponsored, Phase II cancer study with pertuzumab, either alone or with a combination agent, in which at least one dose of pertuzumab was received in the parent study
•Less than 3 months since last dose of pertuzumab on the parent study
•Use of an effective means of contraception for men or for women of childbearing potential
•Granulocyte count \>= 1500/uL
•Platelet count \>= 75,000/uL
•Hemoglobin \>= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbepoetin \[Aranesp(R)\] is permitted)
•Serum bilirubin less than or equal to the upper limit of normal (ULN) (unless due to Gilbert's disease)
•Alkaline phosphatase, AST, and ALT \<= 2.5x ULN (\<= 5x ULN for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases)

Exclusion Criteria

•Recent (within the last 3 months), current, or planned participation in a experimental drug study other than a Genentech-sponsored pertuzumab cancer study
•Any unresolved or irreversible NCI-CTC Grade 3 or 4 adverse event or clinically meaningful cardiac adverse event (any grade) that is pertuzumab-related and ongoing from the parent study
•Recent (within the last 3 months) or current treatment with HER pathway inhibitors other than pertuzumab (e.g., Herceptin(R) \[Trastuzumab\], Iressa\<TM\> \[gefitinib\], Tarceva\<TM\> \[erlotinib hydrochloride\], C225, CI1033, or TAK165) or other monoclonal antibodies
•Clinical evidence of central nervous system or brain metastases
•Ejection fraction ≤50%, as determined by ECHO (or MUGA)
•Uncontrolled hypercalcemia (\> 11.5 mg/dL)
•Recent anthracycline exposure (within the last 3 months) or cumulative exposure of \> 360 mg/m\^2 doxorubicin or equivalent (i.e., liposomal doxorubicin, \> 120 mg/m\^2 mitoxantrone, or \> 90 mg/m\^2 idarubicin)
•Ongoing corticosteroid use (except for subjects who are on stable doses of \< 20 mg of prednisone daily \[or equivalent\] or who are taking corticosteroids for reasons other than cancer)
•Other malignancies (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or squamous cell skin cancer)
•Serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure \> 100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia \[i.e., atrial fibrillation\], paroxysmal supraventricular tachycardia, or controlled hypertension are eligible)

Arms & Interventions

Pertuzumab

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.

Intervention: Pertuzumab

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced an Adverse Event

Time Frame: Baseline to the end of the study (up to 2 years, 5 months)

Secondary Outcomes

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)(Baseline to the end of the study (up to 2 years, 5 months))