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

Phase 2
Not Enrolling
Solid Cancers

Thank you

Trial Information

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

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

- 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 [gefitinib],
Tarceva [erlotinib hydrochloride], C225, CI1033, or TAK165) or other monoclonal

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Selected adverse events

Principal Investigator

Mika Derynck, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

October 2007

Related Keywords:

  • Solid Cancers
  • Advanced solid cancers
  • HER2
  • EGFR