A Study of Pertuzumab in Participants With Prostate Cancer

Roche

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Pertuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02480010

BO17004

Details and patient eligibility

About

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

Enrollment: 68 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than (>) 18 years of age
• Histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal
• Prostate-specific antigen (PSA) values at least 20 ng/mL among those with asymptomatic or mildly symptomatic disease
• Karnofsky performance status (KPS) at least 80 percent (%)
• Castrate testosterone less than (<) 50 ng/dL
• Life expectancy at least 12 weeks
• Left ventricular ejection fraction (LVEF) at least 50%
• Adequate hematologic, hepatic, and renal function

Exclusion criteria

• Prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer
• Systemic corticosteroids within 1 month prior to Screening
• Bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug
• Prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent
• Central nervous system (CNS) or pulmonary metastases
• Other malignancies, except adequately treated basal or squamous cell skin cancer
• Significant cardiovascular disease
• Active/uncontrolled concurrent illness or infection
• Major surgery or traumatic injury within 4 weeks of study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Pertuzumab 1050 mg (Cohort B)

Experimental group

Description:

Participants in Cohort B will receive 1050 mg pertuzumab via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity.

Treatment:

Drug: Pertuzumab

Pertuzumab 420 mg (Cohort A)

Experimental group

Description:

Participants in Cohort A will receive an IV loading dose of 840 milligrams (mg) pertuzumab followed by 420 mg via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity.

Treatment:

Drug: Pertuzumab