Prostate CancerPhase 1NCT00748046
Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton
A Phase 1 study testing Radium-223 chloride (BAY88-8223) in people with Prostate Cancer and Metastases, run by Bayer at 1 site in United States.
Trial summary
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastases, Pharmacokinetics
- What is being tested?
- Radium-223 chloride (BAY88-8223)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
Within the U.S., the trial is conducted under an IND sponsored by Bayer.
- Conditions
- Prostate Cancer, Metastases, Pharmacokinetics
- Being tested
- Radium-223 chloride (BAY88-8223)
- Keywords
- Biodistribution, Radiation dosimetry, Pharmacokinetics, Safety
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 chloride (BAY88-8223)Drug
The required volume of study drug to be administered to a patient was calculated using the patient's body weight.
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 chloride (Xofigo, BAY88-8223) | Experimental | 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). Receives: Drug: Radium-223 chloride (BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 days after injection
Secondary outcomes (3)
Post-treatment PSA effect: PSA decline, time to PSA progression after PSA response
Measured: 1 year
Post-treatment bone markers effect: Changes in bone marker values from pre- to post administration
Measured: 1 year
Circulating tumor cells (CTCs) enumeration and role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J. Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748046
- Sponsor's protocol ID
- 15303
- Other IDs
- BC1-08
- Status last verified
- Jun 2014
- First submitted
- 5 Sep 2008
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Carrasquillo JA, O'Donoghue JA, Pandit-Taskar N, Humm JL, Rathkopf DE, Slovin SF, Williamson MJ, Lacuna K, Aksnes AK, Larson SM, Scher HI, Morris MJ. Phase I pharmacokinetic and biodistribution study with escalating doses of (2)(2)(3)Ra-dichloride in men with castration-resistant metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2013 Sep;40(9):1384-93. doi: 10.1007/s00259-013-2427-6. Epub 2013 May 8.
PubMed 23653243
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00748046
- Acronym / sponsor ID
- 15303
- Conditions
- Prostate Cancer, Metastases, Pharmacokinetics
- Keywords
- Biodistribution, Radiation dosimetry, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
Detailed description
Within the U.S., the trial is conducted under an IND sponsored by Bayer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 chloride (Xofigo, BAY88-8223) | Experimental | Drug: Radium-223 chloride (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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223 chloride (BAY88-8223)The required volume of study drug to be administered to a patient was calculated using the patient's body weight. | Drug | Radium-223 chloride (Xofigo, BAY88-8223) |
Primary outcome
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
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
3 secondary outcomes
Post-treatment PSA effect: PSA decline, time to PSA progression after PSA response
Time frame: 1 year
Post-treatment bone markers effect: Changes in bone marker values from pre- to post administration
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Results publication: PubMed 23653243Carrasquillo JA, O'Donoghue JA, Pandit-Taskar N, Humm JL, Rathkopf DE, Slovin SF, Williamson MJ, Lacuna K, Aksnes AK, Larson SM, Scher HI, Morris MJ. Phase I pharmacokinetic and biodistribution study with escalating doses of (2)(2)(3)Ra-dichloride in men with castration-resistant metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2013 Sep;40(9):1384-93. doi: 10.1007/s00259-013-2427-6. Epub 2013 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radium-223 chloride (BAY88-8223) in people with Prostate Cancer and Metastases, run by Bayer at 1 site in United States.
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 22 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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT00748046, which also lists 1 linked publication.
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 25 Jun 2014.