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Prostate CancerPhase 2NCT00058539

Safety and Efficacy Study of Pertuzumab to Treat Castration-Resistant Prostate Cancer

A Phase 2 study testing rhuMAb 2C4 (pertuzumab) in people with Prostate Cancer, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
rhuMAb 2C4 (pertuzumab)
How many people
42 participants
Where
No sites listed yet
Study dates
Apr 2003to Oct 2004
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age >= 18 years old
  • Histologically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist). Subjects must have documented progression following hormonal therapy withdrawal of >= 4 weeks duration; nilutamide and bicalutamide require 6 weeks withdrawal.
  • Progression of disease after one prior chemotherapy regimen (which must have been taxane-based) for CRPC. Progression is defined as at least one of the following: A minimum of three consecutive serum PSA measurements obtained >= 14 days apart and all within 3 months, with progressively increasing values for two consecutive measurements. The latest value must be obtained within the screening period and must be >= 5 ng/mL; or progression of measurable disease, as defined by RECIST; or progression of bone disease, as defined by the appearance of one or more new bone lesions
  • Orchiectomy, or castrate levels of testosterone maintained by LHRH agonist <70 ng/mL
  • Life expectancy >= 12 weeks
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  • ECOG performance status of 0 or 1
  • Granulocyte count of >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin of >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp] is permitted)
  • Serum bilirubin less than or equal to the upper limit of normal (ULN), unless due to Gilbert's disease, and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases)
  • Serum creatinine <= 1.5 x ULN
  • International normalized ratio (INR) <1.5 and activated partial thromboplastin time (aPTT) <1.5 x ULN (except for subjects receiving warfarin)
  • Willing to complete serial PROSQOLI/PPI evaluations and serial diaries of analgesic use (if necessary)

Who cannot join

  • Prior chemotherapy, radiotherapy, therapeutic radionucleotide or immunotherapy within 4 weeks of Day 1 (the day of the first rhuMAb 2C4 dose). Flutamide therapy, or other second line hormonal therapies should be withdrawn >= 4 weeks prior to Day 1. Bicalutamide and nilutamide therapy should be withdrawn >= 6 weeks prior to starting study medication.
  • Prior treatment with HER2 pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, and TAK165)
  • Treatment with other experimental anticancer agents within 4 weeks prior to Day 1
  • Prior history or clinical evidence of central nervous system or brain metastases
  • Ejection fraction, determined by ECHO, <50%
  • Uncontrolled hypercalcemia (>11.5 mg/dL)
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  • Prior exposure of >360 mg/m2 doxorubicin, >120 mg/m2 mitoxantrone, or >90 mg/m2 idarubicin
  • Ongoing corticosteroid treatment, except for subjects who are on stable doses of <20 mg of prednisone daily (or equivalent), or who are taking corticosteroids for reasons unrelated to prostate cancer
  • History of other malignancies within 5 years prior to Day 1, except for adequately treated basal or squamous cell skin cancer
  • History of serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure >100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible)
  • Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus infection
  • Major surgery or significant traumatic injury within 3 weeks prior to Day 1
  • Inability to comply with study and follow-up procedures
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk for treatment complications

About this study

Official title: A Phase II, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Omnitarg (Pertuzumab) in Subjects With Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.

Conditions
Prostate Cancer
Being tested
rhuMAb 2C4 (pertuzumab)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhuMAb 2C4 (pertuzumab)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria

    Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.

    Measured: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab

  2. Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months

    Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.

    Measured: 3 months

Secondary outcomes (5)

  1. Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])

    PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.

    Measured: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab

  2. Median Time of PFS

    PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.

    Measured: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab

  3. Duration of Response

    Duration of response was defined as the time from the initial CR or PR to the time of disease progression.

    Measured: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab

  4. Percentage of Participants Who Progressed at 3, 6 and 9 Months

    Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.

    Measured: 3, 6, and 9 months

  5. Serum Concentrations of Pertuzumab

    Measured: Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionOct 2004
  4. Study completionOct 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058539
Sponsor's protocol ID
TOC2682g
Status last verified
Jun 2015
First submitted
8 Apr 2003
Last updated
23 Jun 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhuMAb 2C4 (pertuzumab) in people with Prostate Cancer, run by Genentech, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria (time frame: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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