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

Solid Cancers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096941
• Other study ID #: TOC2664g
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2004
• Last updated: May 29, 2015
• Start date: May 2005
• Est. completion date: October 2007

Study information

• Verified date: May 2015
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Cancers

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced an Adverse Event		Baseline to the end of the study (up to 2 years, 5 months)	No
Secondary	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)	No