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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106352
• Other study ID #: 15469
• Secondary ID: BC1-102011-00082
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 16, 2010
• Last updated: July 3, 2015
• Start date: July 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Castration-Resistant Prostate Cancer
• Neoplasm Metastasis
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone.
• Docetaxel
Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m2 is allowed as per the approved docetaxel label.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-escalation: Assessment of dose-limiting toxicities		When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxel	Yes
Primary	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)		12 months	Yes
Secondary	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)		12 months	Yes
Secondary	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		12 months	No
Secondary	Exploratory patient self-reporting of pain intensity		12 months	Yes

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