Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009650

Trial Description

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Title

A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess the safety and efficacy of siltuximab administered in
combination with mitoxantrone and prednisone in participants with metastatic (spread of
cancer cells from one part of the body to another) hormone-refractory (not responding to
treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).

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Brief Summary in Scientific Language

This is a 2-part, open-label (all people know the identity of the intervention) multicenter
(when more than 1 hospital or medical school team work on a medical research study), Phase 2
study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone
versus mitoxantrone in participants with metastatic HRPC who have received 1 prior
Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents)
regimen (pattern of giving treatment). Part 1 of the study is single arm where participants
will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized
portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm
will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will
consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at
a dose of 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute
infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each
3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a
drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m^2). Siltuximab will
be administered at a dose of 6 mg/kilogram intravenously as a 2-hour infusion, starting Day
1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or
up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily
starting with the first administration of Mitoxantrone. The duration of treatment will be a
maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week
12 after the first study agent dosing, then every 9 weeks until the end of treatment and
then once every 3 months until documented disease progression. Tumor (a mass in a specific
area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST)
criteria. There will be short-term follow-up visits (conducted monthly for 2 months),
followed by long-term follow-up visits (conducted once every 3 months). Participants' safety
will also be monitored throughout the study.

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Organizational Data

  •   DRKS00009650
  •   2015/11/12
  •   2006/10/06
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2006-001671-38 
  •   NCT00385827  (ClinicalTrials.gov)
  •   CR012346  (Centocor, Inc.)
  •   C0328T07 
  •   2006-001671-38 
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Health Condition or Problem studied

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

  •   Drug: Mitoxantrone
  •   Drug: Siltuximab
  •   Drug: Prednisone
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); time frame: Baseline up to 12 weeks after last dose administration; An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
- Part 2: Progression Free Survival (PFS); time frame: Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years; The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.

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Secondary Outcome

- Time to Clinical Deterioration (TtCD); time frame: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years; The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.
- Number of Participants With Palliative Response; time frame: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years; Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.
- Number of Participants With Prostate Specific Antigen (PSA) Response; time frame: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years; The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.
- Overall Survival (OS); time frame: Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years; The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2006/11/30
  •   106
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Histologically (the study of tissue under the microscope) or cytologically (the study
of cells) confirmed adenocarcinoma (a malignant epithelial tumor with a glandular
organization) of the prostate

- Radiologically (Gamma and Computed Topography [CT] scans) documented metastatic
disease

- At least 6 weeks of treatment with 1 prior docetaxel-based chemotherapy for
metastatic Hormone Refractory Prostate Cancer (HRPC)

- Disease progression, during or within 6 months of stopping of prior docetaxel-based
therapy, based on one of the following: serum Prostate Specific Antigen (PSA)
progression, defined as a rise in at least 2 consecutive serum PSA values, each
obtained at least 1 week apart or radiologic disease progression: if disease
progression is shown by bone scan only, then disease progression is defined by the
appearance of 2 or more new bone lesions (abnormal area of tissue, such as a wound,
sore, rash, or boil)

- Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50
nanogram per decilliter (ng/dL) by means of pharmacological/chemical castration

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Exclusion Criteria

- No evidence of a brain tumor

- No more than 1 line of chemotherapy for metastatic prostate cancer

- No prior mitoxantrone treatment

- Prior malignancy (other than prostate cancer) except adequately treated superficial
bladder cancer, basal cell or squamous cell carcinoma (type of cancer) of the skin,
or other cancer for which the subject has been disease-free for atleast 3 years

- No Human Immunodeficiency Virus (HIV) (a life-threatening infection that you can get
from an infected person's blood or from having sex with an infected person)
seropositivity or hepatitis (inflammation of the liver) B or C infection

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Addresses

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    • Centocor, Inc.
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    •   [---]*
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    • Centocor, Inc.
    • Centocor, Inc. Clinical Trial 
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    •   [---]*
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    • Centocor, Inc.
    • Centocor, Inc. Clinical Trial 
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    •   [---]*
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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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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2008/11/01
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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.