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Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases


Phase 1
20 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms

Thank you

Trial Information

Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases


Inclusion Criteria:



- Male ≥ 20 years of age

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within
the previous 4 weeks

- Patients who has failed initial hormonal therapy using either an orchiectomy or a
Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen
must first progress through antiandrogen withdrawal prior to being eligible. The
minimum timeframe to document failure of anti-androgen withdrawal will be four weeks

- Progressive castration resistant metastatic disease

- Castrate level of testosterone (<50 ng/dL), treatment to maintain castrate levels of
testosterone must be continued

Exclusion Criteria:

- Has received an investigational drug in the 4 weeks before or is scheduled to
receiving one during or in the 8 weeks after study drug administration.

- Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry
in the study, or has not recovered from acute adverse events as a result of such
therapy

- Has received prior hemibody external radiotherapy

- Has a need for immediate external radiotherapy

- Has received systemic radiotherapy with radium-223, strontium-89, samarium-153,
rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24
weeks prior to administration of study drug

- When receiving bisphosphonates, has changed the dose within 4 weeks before
administration of study drug

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with Critical toxicities

Outcome Description:

Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia

Outcome Time Frame:

Up to day 28

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Institutional Review Board

Study ID:

15354

NCT ID:

NCT01565746

Start Date:

March 2012

Completion Date:

April 2016

Related Keywords:

  • Prostatic Neoplasms
  • BAY88-8223
  • radium-223 dichloride
  • prostate cancer
  • Neoplasms
  • Prostatic Neoplasms

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