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Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component


Inclusion Criteria:



- Written informed consent

- Histologically confirmed adenocarcinoma of prostate

- Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral
orchiectomy

- Progressive metastatic disease

- Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

- Known metastases in the brain

- History of other malignancy within the previous 5 years

- Known gastrointestinal disease or procedure that affects the absorption

- Not able to swallow the study drug

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Karim Fizazi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

3104001

NCT ID:

NCT01317641

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Cleveland ClinicCleveland, Ohio  44195
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Brooklyn Urology Research GroupBrooklyn, New York  11215
The Urology Center of ColoradoDenver, Colorado  80211
Delaware Valley Urology, LLCMt. Laurel, New Jersey  08054
Urology of Virginia, PLLCVirginia Beach, Virginia  23462
Eastern CT Hematology and Oncology AssociatesNorwich, Connecticut  06360