check_circleStudy 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
  • •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).
  • •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
July 2010 - June 2015
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxel
    enhanced_encryption
    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)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Exploratory patient self-reporting of pain intensity
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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
2

Additional Information

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