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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Cancers
• Intervention / Treatment: Drug: Pertuzumab

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)
• Serum creatinine <= 1.5x ULN
• International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5x ULN (except for subjects receiving warfarin)

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)
• Liver disease (including viral or other hepatitis), current alcohol abuse, or cirrhosis
• Known human immunodeficiency virus infection
• Pregnancy or lactation
• Major surgery or significant traumatic injury within 3 weeks prior to Day 1
• Inability to comply with study and follow-up procedures
• Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the subject at high risk from treatment complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Pertuzumab; Pertuzumab was supplied as a single-use liquid formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Experienced an Adverse Event	Baseline to the end of the study (up to 2 years, 5 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Mika Derynck, M.D., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: November 17, 2004
• First Submitted That Met QC Criteria: November 17, 2004
• First Posted (Estimate): November 18, 2004

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: HER2; EGFR; Advanced solid cancers
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: TOC2664g