Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01516762
First received: January 20, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.


Condition Intervention
Prostatic Neoplasms
Drug: Radium-223 dichloride (BAY88-8223)

Study Type: Expanded Access     What is Expanded Access?
Official Title: Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Resource links provided by NLM:


Further study details as provided by Bayer:

Intervention Details:
    Drug: Radium-223 dichloride (BAY88-8223)
    One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
  • Symptomatic is defined as either

    • Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; World Health Organization [WHO] ladder for cancer pain), or
    • Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment)
  • Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met).
  • No intention to use cytotoxic chemotherapy within the next 6 months
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
  • Adequate hematological, liver, and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
    • Platelet count ≥ 100 x10^9/L
    • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count, and platelets
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac Failure New York Heart Association (NYHA) Class III or IV
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia
  • Fecal incontinence
  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: NCT01516762

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix, Arizona, United States, 85040
Scottsdale, Arizona, United States, 85260
United States, California
Greenbrae, California, United States, 94904
La Jolla, California, United States, 92093
San Francisco, California, United States, 94143
Stanford, California, United States, 94305
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Delaware
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington, District of Columbia, United States, 20060
Washington, District of Columbia, United States, 20007
United States, Florida
Fort Myers, Florida, United States, 33901
Miami Beach, Florida, United States, 33140
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Hawaii
Honolulu, Hawaii, United States, 96813-2413
United States, Indiana
Goshen, Indiana, United States, 46526
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
New Orleans, Louisiana, United States, 70112
Shreveport, Louisiana, United States, 71103
United States, Maryland
Baltimore, Maryland, United States, 21287
Baltimore, Maryland, United States, 21229
Baltimore, Maryland, United States, 21201-1595
Bethesda, Maryland, United States, 20889
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0028
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
New Brunswick, New Jersey, United States, 08903-2681
Newark, New Jersey, United States, 07103
United States, New York
New Hyde Park, New York, United States, 11040-1496
New York, New York, United States, 10065
New York, New York, United States, 10016
Syracuse, New York, United States, 13210
United States, North Carolina
Durham, North Carolina, United States, 27710
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43212
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19111-2497
Philadelphia, Pennsylvania, United States, 19401
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29572
Myrtle Beach, South Carolina, United States, 29577
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Houston, Texas, United States, 77030
Plano, Texas, United States, 75093
San Antonio, Texas, United States, 78229
Temple, Texas, United States, 76508
United States, Virginia
Hampton, Virginia, United States, 23666
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98122
United States, West Virginia
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226-3596
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01516762     History of Changes
Other Study ID Numbers: 15995, 2011-004469-33
Study First Received: January 20, 2012
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Radium 223
Alpharadin
Prostate Cancer
Bone metastases
Castrate resistant prostate cancer
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Succinylcholine
Hormones
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 14, 2014