- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748046
Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton
June 24, 2014 updated by: Bayer
Phase 1, Open-label, Single Ascending-dose Study to Assess Safety, Pharmacokinetics, Biodistribution and Radiation Dosimetry of Intravenous Doses of Alpharadin™ Injection (Radium-223 Chloride) in Patients With HRPC and Skeletal Metastases
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Within the U.S., the trial is conducted under an IND sponsored by Bayer.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10065
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Must be ≥18 years of age
- Have histologically or cytologically evidence of adenocarcinoma of the prostate
Have progressive castrate metastatic disease as shown by at least one of the following:
Imaging modalities:
- Radionuclide Bone Scan: New osseous lesions
- MRI or CT: At least a 20% increase in the sum of the LD of target lesions OR
- Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
- Have skeletal metastases confirmed by bone scintigraphy within the last 4 weeks. Evidence of at least 2 bone metastases on bone scan.
- Have castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued.
- Patients who have failed initial hormonal therapy using either an orchiectomy or a GnRH agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks.
- Have Karnofsky performance status ≥60%
- Have a life expectancy ≥6 months
Have the following laboratory requirements:
- White Blood Count (WBC) ≥3,000/mm3
- Absolute Neutrophil Count (ANC) ≥1,500/ mm3
- Platelet (PLT) ≥100,000/ mm3
- Hemoglobin (HGB) ≥10 mg/dl
- Bilirubin ≤2.0 mg/dl (unless the patient has Gilbert's syndrome)
- AST and ALT ≤2,5 times upper institutional limit of the normal range
- Serum creatinine ≤2.0 mg/dl
- Must be able and willing to sign an informed consent indicating that he is aware of the investigational nature of this study in keeping with the policies of the institution and have provided written authorization for use and disclosure of protected health information
- Must be willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination
Exclusion Criteria:
- Have received an investigational drug within 4 weeks prior to the administration of Radium-223 chloride, or is scheduled to receive one during the treatment and post-treatment period
- Have received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from acute adverse events as a result of such therapy
- Have received prior hemibody external radiotherapy
- Have a need for immediate external radiotherapy
- Have received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug
- When receiving bisphosphonates, have changed the dose within 4 weeks before administration of study drug
- 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
- Have imminent or established spinal cord compression based on clinical findings and/or MRI
- Have other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
- Have small cell carcinoma
- Have predominant visceral metastases (≥ 3 lung or liver lesions) or symptomatic lymph-adenopathy (scrotal or pedal edema)
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)
- Crohn's disease or ulcerative colitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Radium-223 chloride (Xofigo, BAY88-8223)
The patients will receive Radium-223 chloride as an escalating dose of either 50, 100 or 200 kBq/kg b.w.
(0.0014, 0.0027 or 0.0054 mCi/kg).
|
The required volume of study drug to be administered to a patient was calculated using the patient's body weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All safety data, including adverse events, occurrence of treatment-emergent adverse events, changes in laboratory variables, vital signs, ECG, physical examination, long term radiation toxicity, including results of bone marrow biopsy
Time Frame: 1 year
|
1 year
|
Biodistribution, dosimetry and pharmacokinetics (whole body activity assessment, the counts in region-of-interest (ROIs) from anterior and posterior whole-body images, and the assay of activity in blood
Time Frame: 6 days after injection
|
6 days after injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-treatment PSA effect: PSA decline, time to PSA progression after PSA response
Time Frame: 1 year
|
1 year
|
Post-treatment bone markers effect: Changes in bone marker values from pre- to post administration
Time Frame: 1 year
|
1 year
|
Circulating tumor cells (CTCs) enumeration and role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J. Morris, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (ACTUAL)
October 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
September 5, 2008
First Submitted That Met QC Criteria
September 5, 2008
First Posted (ESTIMATE)
September 8, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15303
- BC1-08 (OTHER: Algeta ASA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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