Status:
COMPLETED
Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases
Lead Sponsor:
Bayer
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
30+ years
Phase:
PHASE1
Brief Summary
A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, ...
Eligibility Criteria
Inclusion
- ≥ 30 years of age
- has histologically or cytologically confirmed breast or prostate carcinoma
- presents with bony metastases, confirmed by scintigraphic imaging within the previous 4 weeks
- relapsing with new foci in the skeleton after previous external radiotherapy
- has a life expectancy of at least 8 weeks (study part Ia), 5 months for study part Ib
- good performance status; ECOG (Eastern Cooperative Oncology Group) status 0-2
- has normal bone marrow, hepatic, renal and cardiac functions
- clinical chemical laboratory values are within pre-specified range, measured within 7 days prior to dosing day
- for female patients: post-menopausal, surgically sterile or taking adequate contraceptive precaution
Exclusion
- has previously been included in this study. This criterion is applicable for patients that receive a single injection of the study drug, but not for patients to be re-treated, or for those to receive a fractionated dosing regimen (study part Ib).
- has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration. This criterion is applicable for patients that receive a single injection of the study drug and for patients to be re-treated.
- has received any other investigational drug than radium-223 in the 4 weeks before first injection of study drug or is scheduled to receiving one during or in the 8 weeks after the fractionated study drug regimen. This criterion is applicable for patients receiving fractionated dose of the study drug.
- has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study
- has other active, serious, life-threatening disease with a life expectancy of less than 8 weeks
- has any uncontrolled infection
- requires oxygen for pulmonary metastases
- has poor renal function with S-Creatinine \>150 mmol/L (males), \>100 mmol/L (females)
- has heart insufficiency, Class III or IV NYHA (New York Heart Association)
- is pregnant or lactating
- for female patients: of childbearing potential, and not taking adequate contraceptive measures
Key Trial Info
Start Date :
August 14 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2003
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01798108
Start Date
August 14 2001
End Date
June 25 2003
Last Update
May 19 2017
Active Locations (3)
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1
The Norwegian Radium Hospital
Oslo, Norway
2
University Hospital of North Norway
Tromsø, Norway
3
Karolinska University Hospital
Stockholm, Sweden