SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:

• Conditions: Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer); MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022802-41-FI
• Lead Sponsor: Orion Corporation Orion Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-15
• Last Update Posted: 26 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

1. Written informed consent (IC) obtained.
2.Male patients aged 18 years or older.
3.Histologically confirmed adenocarcinoma of prostate.
4.Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy and serum testosterone level < 50 ng/dl (< 0.5 ng/ml, < 1.7 nmol/l) at screening.
5.Progressive metastatic disease during the androgen deprivation, and after the treatment with antiandrogen and antiandrogen withdrawal, demonstrated by 1 or more of the following criteria:
•patients with measurable or non-measurable disease (i.e. no target lesions), progression defined by a new soft tissue lesion or rising PSA value over 2 ng/ml in at least 2 rising successive measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
•patients with measurable disease, progression defined by RECIST 1.1 criteria.
•patients with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.
6.The patient:
•has received 1 or 2 chemotherapy treatments, or
•is ineligible for chemotherapy, or
•is intolerant of chemotherapy, or
•has declined chemotherapy, or
•has no need for chemotherapy yet.
7.The patient has ECOG performance status of 0-1 at screening.
8.The patient has at screening blood counts:
•absolute neutrophil count = 1.5 x 109/l),
•thrombocytes = 100 x 109/l),
•haemoglobin = 10 g/dl (can be post-transfusion).
9.The patient has at screening liver, renal and albumin values of:
•alanine aminotransferase (ALT) or aspartate transaminase (AST) = 2.5 x upper limit of normal (ULN),
•total bilirubin = 2 x ULN,
•creatinine = 1.5 x ULN,
•albumin > 3.0 g/dl
10.Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide at least 6 weeks and other antiandrogens at least 4 weeks prior to the start of the study treatment.
11.Life expectancy of at least 3 months.
12.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1.Known hypersensitivity to the study treatment formulation excipients.
2.The patient has received prior therapy with MDV3100 or any investigational AR antagonist.
3.The patient has received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of the study treatment or has not recovered to grade = 1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and grade 2 neuropathy.
4.Initiation of bisphosphonate therapy within 4 weeks prior to the start of the study treatment. Patients on a stable dose of bisphosphonate for at least for 30 days prior to the start of the study treatment can continue the treatment during the study.
5.Therapy with estrogen within 30 days prior the start of the study treatment. 6.Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of the study treatment.
7.Use of systemic corticosteroid with dose greater than the equivalent of 10 mg of prednisone/day within 30 days prior to the start of the study treatment. Patients on a stable maintenance dose of corticosteroid = 10 mg/day can continue the treatment during the study.
8.Prior use of any herbal products known to decrease PSA levels (e.g. PC-SPES or saw palmetto) within 30 days prior the start of the study treatment.
9.Known metastases in the brain.
10.History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
11.Major surgery within 4 weeks prior to the start of the study treatment. 12.Serious persistent infection within 14 days prior to the start of the study treatment.
13.Known gastrointestinal disease or procedure that affects the absorption of the study treatment.
14.Serious concurrent medical condition or psychiatric illness.
15.History of congestive heart failure New York heart association (NYHA) class III or IV or uncontrolled hypertension at screening.
16.History or family history of long QTc syndrome.
17.Abnormalities in centrally read 12-lead ECG considered by the investigator to be clinically significant or PR interval > 200 ms or prolongation or shortening of the rate-corrected (Fridericia) QT interval (repeated demonstration of QTc interval > 450 ms or < 300 ms) at screening
18.The patient has received any investigational treatment within 30 days prior to the start of the study treatment.
19.Known history of hepatitis B, or hepatitis C.
20.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures.
21.The patient is not able to swallow the study treatment capsules.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified