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A Phase II, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Omnitarg (Pertuzumab) in Subjects With Castration-Resistant Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Omnitarg (Pertuzumab) in Subjects With Castration-Resistant Prostate Cancer

Inclusion Criteria:

- Signed informed consent

- Age >= 18 years old

- Histologically documented adenocarcinoma of the prostate, clinically refractory or
resistant to hormone therapy, as assessed by progression following at least one
hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone [LHRH]
agonist). Subjects must have documented progression following hormonal therapy
withdrawal of >= 4 weeks duration; nilutamide and bicalutamide require 6 weeks

- Progression of disease after one prior chemotherapy regimen (which must have been
taxane-based) for CRPC. Progression is defined as at least one of the following: A
minimum of three consecutive serum PSA measurements obtained >= 14 days apart and all
within 3 months, with progressively increasing values for two consecutive
measurements. The latest value must be obtained within the screening period and must
be >= 5 ng/mL; or progression of measurable disease, as defined by RECIST; or
progression of bone disease, as defined by the appearance of one or more new bone

- Orchiectomy, or castrate levels of testosterone maintained by LHRH agonist <70 ng/mL

- Life expectancy >= 12 weeks

- ECOG performance status of 0 or 1

- Granulocyte count of >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin of >=
9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other
approved hematopoietic growth factors; darbopoeitin [Aranesp] is permitted)

- Serum bilirubin less than or equal to the upper limit of normal (ULN), unless due to
Gilbert's disease, and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT, AST, and
alkaline phosphatase <= 5 x ULN for subjects with liver metastases; no alkaline
phosphatase upper limit for subjects with bone metastases)

- Serum creatinine <= 1.5 x ULN

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

- Willing to complete serial PROSQOLI/PPI evaluations and serial diaries of analgesic
use (if necessary)

Exclusion Criteria:

- Prior chemotherapy, radiotherapy, therapeutic radionucleotide or immunotherapy within
4 weeks of Day 1 (the day of the first rhuMAb 2C4 dose). Flutamide therapy, or other
second line hormonal therapies should be withdrawn >= 4 weeks prior to Day 1.
Bicalutamide and nilutamide therapy should be withdrawn >= 6 weeks prior to starting
study medication.

- Prior treatment with HER2 pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa
[gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, and TAK165)

- Treatment with other experimental anticancer agents within 4 weeks prior to Day 1

- Prior history or clinical evidence of central nervous system or brain metastases

- Ejection fraction, determined by ECHO, <50%

- Uncontrolled hypercalcemia (>11.5 mg/dL)

- Prior exposure of >360 mg/m2 doxorubicin, >120 mg/m2 mitoxantrone, or >90 mg/m2

- Ongoing corticosteroid treatment, except for subjects who are on stable doses of <20
mg of prednisone daily (or equivalent), or who are taking corticosteroids for reasons
unrelated to prostate cancer

- History of other malignancies within 5 years prior to Day 1, except for adequately
treated basal or squamous cell skin cancer

- History of 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 within 6 months
prior to Day 1, or unstable symptomatic arrhythmia requiring medication (subjects
with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal
supraventricular tachycardia, or controlled hypertension are eligible)

- Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or

- Known human immunodeficiency virus infection

- Major surgery or significant traumatic injury within 3 weeks prior to Day 1

- Inability to comply with study and follow-up procedures

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk for treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

June 2004

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms