Study Completed

Bone Metastases, Castration-Resistant Prostate Cancer

Bayer Identifier:

15469

ClinicalTrials.gov Identifier:

NCT01106352

EudraCT Number:

2011-000822-31

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

Male

Age

18 - N/A

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

Trial Dates

July 2010 - June 2015

Phase

Phase 1/Phase 2

Could I Receive a placebo

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where 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 toxicities
Time Frame:
When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxel
Safety Issue:
Yes
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)
Time Frame:
12 months
Safety Issue:
Yes

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)
Time Frame:
12 months
Safety Issue:
Yes
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 survival
Time Frame:
12 months
Safety Issue:
No
Exploratory patient self-reporting of pain intensity
Time Frame:
12 months
Safety Issue:
Yes

Trial design

A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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