BC1-10 Combo - for healthcare professionals.

A phase I/IIa study of safety and efficacy of Alpharadin^®® with docetaxel in patients with bone metastases from castration-resistant prostate cancer (trial BC1-10)

Algeta initiated a new open-label, randomized phase I/IIa study (BC1-10) in June 2010 to investigate whether Alpharadin^® and docetaxel chemotherapy can be used safely together to treat men with bone metastases resulting from CRPC.

The trial aims to recruit up to 60 patients and is being conducted at the Memorial Sloan-Kettering Cancer Center in New York and up to nine other centers in the USA.

The objective of the study is to establish a recommended dose of Alpharadin^® to be used in combination with docetaxel in men with bone metastases from CRPC, to investigate safety and to explore efficacy of the recommended combination dose.

Patient enquiries:

Below is a brief description of a phase I/IIa clinical study with Alpharadin^® in combination with chemotherapy (docetaxel), including main inclusion and exclusion criteria. Please refer to www.clinicaltrial.gov for additional information.

Patients interested in participating in this trial are advised to discuss this information with their medical doctor.

For further information from Algeta:
E-mail to alpharadin@algeta.com

Phone: +47 23 00 79 90

Summary:

This is a phase I/IIa study to establish a dose regimen for Alpharadin^® (radium-223 chloride) to be used in combination with a standard docetaxel treatment regimen, and to investigate the safety and explore efficacy of Alpharadin^® used in this combination in patients with bone metastases from castration-resistant prostate cancer (CRPC). 9-18 patients are planned to be enrolled into the phase I portion of the trial (dose-escalation) while approximately 42 patients are planned to be randomized in the phase IIa portion (expanded safety cohort).

In the expanded safety cohort, 2/3 of the patients are planned to be randomized to receive Alpharadin^® every 6 weeks at a dose of 50or25 kBq/kg b.w. for a maximum of 5 or 10 injections as an add-on to a standard docetaxel treatment regimen. 1/3 of the patients will be randomized to receive a standard docetaxel treatment regimen alone. The dose and interval of Alpharadin^® to be administered in the expanded safety cohort is dependent on the outcome of the dose-escalating portion of the study. Patients will be monitored for 1 year from start of study treatment.

Target Population:

Patients with bone metastases from CRPC intended for treatment with docetaxel

Study Objectives:

Establish a recommended dose of Alpharadin^® to be used with a standard docetaxel treatment regimen
Investigate safety and explore efficacy of the recommended dose of Alpharadin^® used with the standard treatment regimen of docetaxel in patients with bone metastases from castration-resistant prostate cancer.
Evaluate the feasibility of patient self-reporting of pain intensity and analgesic use via an interactive voice response (IVR) system.

Main Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate.
Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 12 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 of similar).

Main 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 >= 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 ¡Ý2cm]), as assessed by CT scan 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 hematological 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.

Coordinating investigator for the study:

Michael J Morris, MD
Memorial Sloan-Kettering Cancer Center
1275 York Avenue
New York, NY 10021
USA

Other sites will be listed at www.clinicaltrial.gov as they are open for patient recruitment.