A Study of Pertuzumab in Participants With Prostate Cancer
NCT ID: NCT02480010
Last Updated: 2015-09-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
68 participants
INTERVENTIONAL
2003-09-30
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pertuzumab 1050 mg (Cohort B)
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.
Pertuzumab
Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.
Pertuzumab 420 mg (Cohort A)
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.
Pertuzumab
Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.
Interventions
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Pertuzumab
Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Lyon, , France
Montpellier, , France
Berlin, , Germany
Parma, , Italy
Roma, , Italy
Rotterdam, , Netherlands
Barcelona, , Spain
Valencia, , Spain
Cardiff, , United Kingdom
Sutton, , United Kingdom
Weston-super-Mare, , United Kingdom
Countries
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Other Identifiers
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BO17004
Identifier Type: -
Identifier Source: org_study_id
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