A Study of Pertuzumab in Participants With Prostate Cancer

NCT02480010 | Terminated Phase 2 Results

• 1 other identifier: BO17004
• Study Type: interventional
• Target: 68
• Locations: 6 countries
• Sites: 11

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab

  Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.

  Screening, Every 3 weeks up to Week 24

Secondary Outcomes (19)

• Time to Disease Progression

  Screening, Every 3 weeks up to a maximum of 18 months

• Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

  Screening, Weeks 6, 12, 24, 36 and 48

• Time to Response

  Screening, Every 3 weeks for a maximum of 18 months

• Duration of Response According to PSA Levels

  Baseline, Every 3 weeks for a maximum of 18 months

• Duration of Response According to RECIST Criteria

  Baseline, Weeks 6, 12, 24, 36 and 48

Study Arms (2)

Pertuzumab 1050 mg (Cohort B)

EXPERIMENTAL

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.

Drug: Pertuzumab

Pertuzumab 420 mg (Cohort A)

EXPERIMENTAL

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.

Drug: Pertuzumab

Interventions

Pertuzumab DRUG

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.

Also known as: Perjeta

Pertuzumab 1050 mg (Cohort B); Pertuzumab 420 mg (Cohort A)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Unknown Facility

Lyon, 69008, France

Location

Unknown Facility

Montpellier, 34298, France

Location

Unknown Facility

Berlin, 12203, Germany

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Roma, 00152, Italy

Location

Unknown Facility

Rotterdam, 3075 EA, Netherlands

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Cardiff, CF14 2TL, United Kingdom

Location

Unknown Facility

Sutton, SM2 5PT, United Kingdom

Location

Unknown Facility

Weston-super-Mare, BS23 4TQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

The study was terminated at the time of interim analysis since none of the participants showed a PSA response.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 24, 2015
• Study Start: September 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: September 18, 2015
• Results First Posted: September 18, 2015

Record last verified: 2015-08

Locations

DE (1); ES (2); IT (2); NL (1); GB (3); FR (2)