BAY88-8223, Dose Finding Study in Patients With HRPC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00337155
First received: June 13, 2006
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.


Condition Intervention Phase
Prostate Cancer
Neoplasm Metastasis
Drug: Radium-223 dichloride (BAY88-8223)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomised, Dose Finding, Repeat Dose, Phase II, Multicentre Study of Alpharadin® for the Treatment of Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of participants in each dose group with a confirmed PSA response [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
    PSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks.


Secondary Outcome Measures:
  • The maximum percent decrease in PSA level compared to baseline [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Time to PSA Progression [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baseline [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Total number of SRE per patient [ Time Frame: 24 weeks, 12 months, 24months ] [ Designated as safety issue: No ]
  • Pain Assessment and analgesic consumption [ Time Frame: 24 weeks, 12 months, 24months ] [ Designated as safety issue: No ]
  • Time to death from first treatment [ Time Frame: 24 weeks, 12 months, 24months ] [ Designated as safety issue: No ]
  • Time to Skeletal Related Events (SRE) [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Adverse events, blood chemistry and haematological toxicity [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1
25 kBq/kg b.w., 3 times at 6 week intervals
Drug: Radium-223 dichloride (BAY88-8223)
3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.
Experimental: Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 2
50 kBq/kg b.w., 3 times at 6 week intervals
Drug: Radium-223 dichloride (BAY88-8223)
3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.
Experimental: Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 3
80 kBq/kg b.w., 3 times at 6 week intervals
Drug: Radium-223 dichloride (BAY88-8223)
3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Hormone refractory with evidence of rising PSA:

    • Patient must be maintained on androgen ablation therapy with LHRH agonist (stable dose for at least 8 weeks prior to study entry), or have undergone orchiectomy
    • Serum testosterone level is required to be ≤ 50 ng/dl
    • Patients who have received prior hormonal drug therapy:

      • Flutamide, nilutamide or cyproterone acetate must have stopped at least four weeks prior to study drug administration and progression must have been demonstrated since cessation;
      • Bicalutamide must have stopped at least six weeks prior to study drug administration and progression must have been demonstrated since cessation
    • Elevated and rising PSA:

      • Baseline PSA level ≥ 10 ng/ml
      • Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur a minimum of 1 week from the reference value (measure 1. This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the patient will still be eligible provided the next PSA measure (measure 4)is found to be greater than the second PSA value(measure 2).3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
  • Performance status: ECOG 0-2
  • Life expectancy: At least 6 months
  • Laboratory requirements:

    • Neutrophil count ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x109/L
    • Haemoglobin ≥ 95 g/L
    • Total bilirubin level within normal institutional limits
    • ASAT and ALAT ≤ 2,5 times upper institutional limit of the normal range
  • The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination
  • The patient has been fully informed about the study and has signed the informed consent form

Exclusion Criteria:

  • Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
  • Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • More than one regimen of previous cytotoxic chemotherapy
  • Has received prior hemibody external radiotherapy
  • Has a need for immediate external radiotherapy
  • Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
  • Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for ≥ 12 weeks before administration of study drug.
  • Patients who are ≤ 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
  • Patients who have started or stopped systemic steroids, within a week prior to study drug administration
  • Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
  • Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within six weeks before administration of study drug; Lung lesions from prostate cancer as assessed by chest X-ray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable
  • Bulky loco-regional disease
  • Any other serious illness or medical condition, for example:

    • any uncontrolled infection
    • any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV
    • Crohns disease or ulcerative colitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337155

Locations
United Kingdom
Sutton, Surrey, United Kingdom, SM2 5RT
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00337155     History of Changes
Other Study ID Numbers: 15304, 2005-003680-22, BC1-04
Study First Received: June 13, 2006
Last Updated: June 24, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bayer:
Recurrent Prostate Cancer
metastatic Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Succinylcholine
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014