check_circleStudy Completed
Bone Metastases, Castration-Resistant Prostate Cancer
Bayer Identifier:
15469
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
Trial purpose
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
63Trial Dates
July 2010 - June 2015Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | New York, 10065, United States | |
Completed | Baltimore, 21287, United States | |
Completed | Boston, 02115-6013, United States | |
Completed | Evanston, 60201, United States | |
Completed | Seattle, 98109, United States | |
Completed | San Francisco, 94115, United States | |
Completed | VILLEJUIF CEDEX, 94805, France |
Primary Outcome
- Dose-escalation: Assessment of dose-limiting toxicitiesdate_rangeTime Frame:When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxelenhanced_encryptionYesSafety Issue:
- Expanded safety cohort: Safety of combining Alpharadin with docetaxel (incidence and severity of adverse events and serious adverse events, changes from baseline in laboratory variables, vital signs and physical examination)date_rangeTime Frame:12 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Signs of long-term radiation toxicity: incidence of manifestations of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukaemia, myelodysplastic syndrome, and aplastic anaemia)date_rangeTime Frame:12 monthsenhanced_encryptionYesSafety Issue:
- Exploratory efficacy measurements of Alpharadin in combination with docetaxel versus docetaxel alone such as changes in bone markers, PSA and CTC, time to progression and overall survivaldate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Exploratory patient self-reporting of pain intensitydate_rangeTime Frame:12 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2