Clinical trial NCT02480010: A Study of Pertuzumab in Participants With Prostate Cancer
Official title: An Open Label, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of a Recombinant Humanized Antibody to HER2 (Pertuzumab) Administered Every 3 Weeks to Patients With Hormone-Refractory Prostate Cancer Who Have Not Been Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 68
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab
timeFrame: Screening, Every 3 weeks up to Week 24
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: Screening, Every 3 weeks up to a maximum of 18 months
measure: Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
timeFrame: Screening, Weeks 6, 12, 24, 36 and 48
measure: Time to Response
timeFrame: Screening, Every 3 weeks for a maximum of 18 months
measure: Duration of Response According to PSA Levels
timeFrame: Baseline, Every 3 weeks for a maximum of 18 months
measure: Duration of Response According to RECIST Criteria
timeFrame: Baseline, Weeks 6, 12, 24, 36 and 48
measure: Percentage of Participants Without Progression
timeFrame: Screening, Weeks 3, 6, 9 and 12
measure: Time to Prostate Cancer Pain Progression
timeFrame: Every 3 weeks up to a maximum of 18 weeks
measure: Overall Survival
timeFrame: Screening, Every 3 weeks up to a maximum of 18 months
measure: Time to Treatment Failure
timeFrame: Every 3 weeks up to a maximum of 18 weeks
measure: Change From Baseline in Bone Alkaline Phosphatase
timeFrame: Screening, Weeks 6, 12, 24, 36 and 48
measure: Change From Baseline in N-Telopeptide
timeFrame: Screening, Weeks 6, 12, 24, 36 and 48
measure: Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Maximum Plasma Concentration of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Terminal Elimination Half-Life (t1/2) of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Serum Clearance of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Volume of Distribution at Steady State of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
measure: Mean Residence Time (MRT) of Pertuzumab
timeFrame: Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1
Other outcomes:
Locations:
city: Lyon
country: France
city: Montpellier
country: France
city: Berlin
country: Germany
city: Parma
country: Italy
city: Roma
country: Italy
city: Rotterdam
country: Netherlands
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Cardiff
country: United Kingdom
city: Sutton
country: United Kingdom
city: Weston Super Mare
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: