Trial Condition(s):

Bone Metastases, Castration-Resistant Prostate Cancer

A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

Bayer Identifier:

15469

ClinicalTrials.gov Identifier:

NCT01106352

EudraCT Number:

2011-000822-31

Study Completed

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.

Inclusion Criteria
•Histologically or cytologically confirmed adenocarcinoma of the prostate.
•Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
•Known castration-resistant disease
•Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
•Life expectancy at least 6 months.
•Acceptable hematology and serum biochemistry screening values
•Eligible for use of docetaxel according to the product information (package insert or similar).
Exclusion Criteria
•Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
•Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
•Has an immediate need for radiotherapy.
•Has received prior hemibody external radiotherapy .
•Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
•Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
•Has received more than ten previous infusions of docetaxel.
•Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
•Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
•Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
•Has received prior treatment with Alpharadin.
•Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
•Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
•Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
•Uncontrolled loco-regional disease.
•Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
•Has imminent or established spinal cord compression based on clinical findings and/or MRI.
•Unmanageable fecal incontinence

Trial Summary

Enrollment Goal
63
Trial Dates
black-arrow
Phase
1/2
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New York, United States, 10065

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21287

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02115-6013

Status
Completed
 
Locations

Investigative Site

Evanston, United States, 60201

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98109

Status
Completed
 
Locations

Investigative Site

San Francisco, United States, 94115

Status
Completed
 
Locations

Investigative Site

VILLEJUIF CEDEX, France, 94805

Status
Completed
 

Trial Design