Clinical trial · Interventional
A Study of Pertuzumab in Participants With Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated at the time of interim analysis since none of the participants showed a PSA response.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pertuzumab 1050 mg (Cohort B)
- 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.
- interventionNames
- Drug: Pertuzumab
- type
- EXPERIMENTAL
- label
- Pertuzumab 420 mg (Cohort A)
- 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.
- interventionNames
- Drug: Pertuzumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available