Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010313

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010313
  •   2016/04/14
  •   2015/06/05
  •   no
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Secondary IDs

  •   NCT02480010  (ClinicalTrials.gov)
  •   BO17004  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Pertuzumab
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab; time frame: Screening, Every 3 weeks up to Week 24; 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.

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Secondary Outcome

- Time to Disease Progression; time frame: Screening, Every 3 weeks up to a maximum of 18 months; Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.
- Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria; time frame: Screening, Weeks 6, 12, 24, 36 and 48; Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.
- Time to Response; time frame: Screening, Every 3 weeks for a maximum of 18 months; Time to response was the date of the first documentation of PSA response.
- Duration of Response According to PSA Levels; time frame: Baseline, Every 3 weeks for a maximum of 18 months; Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.
- Duration of Response According to RECIST Criteria; time frame: Baseline, Weeks 6, 12, 24, 36 and 48; For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.
- Percentage of Participants Without Progression; time frame: Screening, Weeks 3, 6, 9 and 12; Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.
- Time to Prostate Cancer Pain Progression; time frame: Every 3 weeks up to a maximum of 18 weeks; Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.
- Overall Survival; time frame: Screening, Every 3 weeks up to a maximum of 18 months; Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.
- Time to Treatment Failure; time frame: Every 3 weeks up to a maximum of 18 weeks; Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.
- Change From Baseline in Bone Alkaline Phosphatase; time frame: Screening, Weeks 6, 12, 24, 36 and 48; Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).
- Change From Baseline in N-Telopeptide; time frame: Screening, Weeks 6, 12, 24, 36 and 48; In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).
- Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab; time frame: 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; The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (µg*day/mL)
- AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab; time frame: 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; The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
- Maximum Plasma Concentration of Pertuzumab; time frame: 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; Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).
- Time to Maximum Plasma Concentration (Tmax) of Pertuzumab; time frame: 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; Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.
- Terminal Elimination Half-Life (t1/2) of Pertuzumab; time frame: 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; t1/2 is the time in days required for the concentration of the drug to reach half of its original value
- Serum Clearance of Pertuzumab; time frame: 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; Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).
- Volume of Distribution at Steady State of Pertuzumab; time frame: 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; The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.
- Mean Residence Time (MRT) of Pertuzumab; time frame: 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; MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.

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Countries of Recruitment

  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2003/09/30
  •   68
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   19   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting stopped after recruiting started
  •   2005/09/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.