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PK in Pts With HRPC & Skeletal Metastes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00667537
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 24, 2008
First Posted Date  ICMJE April 28, 2008
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
  • Estimation of whole-body retention of radioactivity at each imaging time post-injection [ Time Frame: 1 week ]
  • Estimation of the individual organ uptake/retention of radioactivity at each time-point post injection [ Time Frame: 1 week ]
  • Estimate retention of administered radioactivity in blood [ Time Frame: Up to 1 week ]
  • Estimation of elimination of radioactivity in urine and faeces [ Time Frame: 2 days ]
  • Calculation of estimated absorbed radiation dose to target organs [ Time Frame: 1 week ]
  • Pharmacokinetics [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2008)
Radiation Dosimetry: • Estimation of whole-body retention • Estimation of organ uptake/retention • Estimate retention in blood • Estimation of elimination • Calc. of estimated absorbed radiation dose to target organs. • Pharmacokinetics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
  • Comparison of the biodistribution and dosimetry after the first and second injection [ Time Frame: 7 weeks ]
  • Prostate specific antigen (PSA) response [ Time Frame: At baseline, before injections, and at 2 month intervals during the 12 month follow up period ]
    PSA decline, defined as the number of patients with a confirmed ≥50% reduction in PSA level after treatment with respect to the pre-injection PSA level and the time to PSA progression after PSA response
  • Survival [ Time Frame: 6 and 12 months after the first injection ]
  • Adverse events [ Time Frame: 1 year ]
  • Laboratory variables; serum biochemistry and haematology [ Time Frame: 1 year ]
  • Vital signs [ Time Frame: 12 weeks ]
    Systolic/diastolic blood pressure, respiratory rate, heart rate and body temperature
  • ECG (12 leads) [ Time Frame: 12 weeks ]
    Electrocardiogram (12 leads)
  • Physical examination [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2008)
  • Imaging: • Comparison of the biodistribution and dosimetry after the 1. and 2. injection • Comparison of the biodistribution and dosimetry of the study drug between different patients • Change in metabolic activity in bone metastases
  • Safety: • Adverse events • Laboratory variables • Vital signs • ECG (12 leads) • Physical examination
  • PSA response: • PSA decline, defined as number of patients with a confirmed ≥ 50% reduction in PSA level after treatment with respect to the pre-injection PSA level. • The time to PSA progression after PSA response.
  • Survival: Survival data will be collected at 6 and 12 months after first injection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK in Pts With HRPC & Skeletal Metastes
Official Title  ICMJE A Phase I, Open-label, Dosimetry, Biodistribution and Pharmacokinetic Study of Alpharadin™ in Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases
Brief Summary

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart).

Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: Radium-223 chloride (Xofigo®, BAY88-8223) injection
Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration
Study Arms  ICMJE Experimental: Radium-223 chloride
IV administrations of 100 kBq/kg b.w (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization). Two administrations took place with an interval of 6 weeks
Intervention: Drug: Radium-223 chloride (Xofigo®, BAY88-8223) injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2008)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Hormone refractory with evidence of rising prostate-specific antigen (PSA): Subject must be maintained on androgen ablation therapy with luteinizing hormone-releasing hormone agonist or have undergone bilateral orchiectomy
  • Serum testosterone level required to be ≤50 ng/dL
  • Subjects who have received prior antiandrogen drug therapy: Flutamide, nilutamide, or cyproterone acetate must have stopped at least 4 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation; bicalutamide must have stopped at least 6 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation
  • PSA progression: Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur at a minimum of 1 week from the reference value (measure 1). This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the subject will still be eligible provided the next PSA measure (measure 4) is found to be greater than the second PSA value (measure 2)
  • Skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
  • Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
  • Life expectancy: ≥6 months
  • Laboratory requirements: Neutrophil count ≥1.5 x 109/L, platelet count ≥100 x109/L, haemoglobin ≥95 g/L, total bilirubin level within normal institutional limits, aspartate aminotransferase and alanine aminotransferase ≤2.5 times upper institutional limit of the normal range, S Creatinine ≤1.5 times upper institutional limit of the normal range

Exclusion Criteria:

  • Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
  • Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • More than one regimen of previous cytotoxic chemotherapy
  • Has received prior hemibody external radiotherapy
  • Has a need for immediate external radiotherapy
  • Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
  • Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for >/= 12 weeks before administration of study drug
  • Patients who are </= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
  • Patients who have started or stopped systemic steroids, within a week prior to study drug administration, or are expected to be subject to changes in the systemic steroid medication
  • Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
  • Visceral (e.g. liver, lung) metastases from prostate cancer as assessed by abdominal/ pelvic CT or chest radiograph within six weeks before administration of study drug
  • Lymph node metastases with short-axis diameter greater than 2 cm
  • Bulky loco-regional disease
  • Any other serious illness or medical condition, for example: any uncontrolled infection, any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV), Crohns disease or ulcerative colitis
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00667537
Other Study ID Numbers  ICMJE 15302
2006-006101-88 ( EudraCT Number )
BC1-05 ( Other Identifier: Algeta ASA number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP