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Completed

NCT Number: NCT01317641

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Klinika onkologie a radioterapie LFUK a FN, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ODM-201

Drug

ODM-201 administered orally daily

Primary outcomes

  1. Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)

    Time frame: Up to 28 days for each cohort

    A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.

  2. Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose

    Time frame: Up to 28 days for each cohort

    The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)

Secondary outcomes

  1. Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group

    Time frame: 3 months

    Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor

  2. Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group

    Time frame: 3 months

    Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor

  3. Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group

    Time frame: 3 months

    Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor

  4. Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group

    Time frame: 3 months

    Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.

  5. Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group

    Time frame: 3 months

    Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.

  6. Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group

    Time frame: 3 months

    Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.

  7. Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group

    Time frame: 3 months

    Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

  8. Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group

    Time frame: 3 months

    Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

  9. Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group

    Time frame: 3 months

    Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

  10. Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state

    Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

    AUC(0-8h)

  11. Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state

    Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

  12. Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1

    Time frame: 1 day

  13. Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state

    Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

    AUC(0-8h)

  14. Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state

    Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

  15. Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 17, 2011
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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