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

Sponsor
Orion Corporation, Orion Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01317641
Collaborator
Endo Pharmaceuticals (Industry)
136
Enrollment
23
Locations
4
Arms
28
Duration (Months)
5.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: ODM-201 Phase I

Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 1

Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 2

Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 3

Drug: ODM-201
ODM-201 administered orally daily

Outcome Measures

Primary Outcome Measures

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Urology Center of Colorado Wheat Ridge Colorado United States 80211
2 Eastern CT Hematology and Oncology Associates Norwich Connecticut United States 06360
3 Urology Health Team PLLC Ocala Florida United States 34474
4 Chesapeake Urology Research Associates Baltimore Maryland United States 21327
5 Delaware Valley urology, LLC Voorhees New Jersey United States 08043
6 Brooklyn Urology Research Group Brooklyn New York United States 11215
7 Cleveland Clinic Cleveland Ohio United States 44195
8 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
9 Klinika onkologie a radioterapie LFUK a FN Hradec Králové Czech Republic
10 Fakultni Nemonicnice Olomouc Olomouc Czech Republic
11 Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo Znojmo Czech Republic
12 East-Tallinn Central Hospital Talinn Estonia
13 Helsinki University Central Hospital Helsinki Finland
14 Kuopio University Hospital Kuopio Finland
15 Oulu University Hospital Oulu Finland
16 Tampere University Hospital Tampere Finland
17 Turku University Hospital Turku Finland
18 Saint Louis Hospital Paris France
19 Institut Gustave Roussy Villejuif France
20 Queen Elizabeth Hospital Birmingham United Kingdom
21 Velindre Cancer Centre Cardiff United Kingdom
22 Christie Hospital Manchester United Kingdom
23 Churchill Hospital Oxford United Kingdom

Sponsors and Collaborators

  • Orion Corporation, Orion Pharma
  • Endo Pharmaceuticals

Investigators

  • Principal Investigator: Karim Fizazi, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01317641
Other Study ID Numbers:
  • 3104001
First Posted:
Mar 17, 2011
Last Update Posted:
Mar 29, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details Participants were enrolled at 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013
Pre-assignment Detail 136 participants participated in the study, including 24 enrolled in Phase 1 and 112 in Phase 2 randomly assigned to 200 mg, 400 mg or 1400 mg daily doses and stratified by previous chemotherapy and treatment with CYP17 inhibitor. Two participants assigned to treatment did not start ODM-201, and were therefore excluded from analyses populations.
Arm/Group Title Phase 1: ODM-201 200 mg/Day Phase 1: ODM-201 400 mg/Day Phase 1: ODM-201 600 mg/Day Phase 1: ODM-201 1000 mg/Day Phase 1: ODM-201 1400 mg/Day Phase 1: ODM-201 1800 mg/Day Phase 2: ODM-201 200mg/Day Phase 2: ODM-201 400mg/Day Phase 2: ODM-201 1400mg/Day
Arm/Group Description Dose escalation Dose escalation Dose escalation Dose escalation Dose escalation Dose escalation Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
Period Title: Overall Study
STARTED 4 7 3 4 3 3 38 38 36
COMPLETED 3 6 3 3 3 3 35 33 31
NOT COMPLETED 1 1 0 1 0 0 3 5 5

Baseline Characteristics

Arm/Group Title Phase 1, 200mg/Day ODM-201 Phase 1, 400mg/Day ODM-201 Phase 1, 600mg/Day ODM-201 Phase 1, 1000mg/Day ODM-201 Phase 1, 1400mg/Day ODM-201 Phase 1, 1800mg/Day ODM-201 Phase 2 (200mg/Day ODM-201) Phase 2 (400mg/Day ODM-201) Phase 2 (1400mg/Day ODM-201) Total
Arm/Group Description Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose escalation. Participants received twice daily of oral ODM-201 continuously. Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously. Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously. Total of all reporting groups
Overall Participants 4 7 3 4 3 3 38 37 35 134
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
73
(1.4)
71.9
(8.5)
65.3
(3.5)
65.8
(11.2)
67.7
(5.5)
67.7
(3.2)
68.3
(7.0)
69.1
(7.4)
71.3
(8.0)
69.4
(7.4)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Male
4
100%
7
100%
3
100%
4
100%
3
100%
3
100%
38
100%
37
100%
35
100%
134
100%

Outcome Measures

1. Primary Outcome
Title Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
Description 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.
Time Frame Up to 28 days for each cohort

Outcome Measure Data

Analysis Population Description
Safety population included all participants in Phase 1 who received any study drug.
Arm/Group Title Phase 1: ODM-201 200 mg/Day Phase 1: ODM-201 400 mg/Day Phase 1: ODM-201 600 mg/Day Phase 1: ODM-201 1000 mg/Day Phase 1: ODM-201 1400 mg/Day Phase 1: ODM-201 1800 mg/Day
Arm/Group Description Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously.
Measure Participants 4 7 3 4 3 3
Number [events]
0
0
0
0
0
0
2. Primary Outcome
Title Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
Description The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Time Frame Up to 28 days for each cohort

Outcome Measure Data

Analysis Population Description
Safety population included all participants in Phase 1 who received any study drug.
Arm/Group Title Phase 1: ODM-201 200 mg/Day Phase 1: ODM-201 400 mg/Day Phase 1: ODM-201 600 mg/Day Phase 1: ODM-201 1000 mg/Day Phase 1: ODM-201 1400 mg/Day Phase 1: ODM-201 1800 mg/Day
Arm/Group Description Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously. Participants received twice daily of oral ODM-201 continuously.
Measure Participants 4 7 3 4 3 3
Number [DLTs]
0
0
0
0
0
0
3. Secondary Outcome
Title Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable chemotherapy-naïve and CYP17i-naïve patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 600mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201 1800mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) phase 1 phase 1 expanded dose level (phase 1 + phase 2) phase 1
Measure Participants 12 13 2 1 7 2
Number [participants]
6
150%
9
128.6%
1
33.3%
1
25%
6
200%
2
66.7%
4. Secondary Outcome
Title Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable post-chemotherapy and CYP17i-naïve patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 600mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201 1800mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 Phase 1 expanded dose level (phase 1 + phase 2) Phase 1
Measure Participants 11 9 1 1 11 1
Number [participants]
5
125%
1
14.3%
1
33.3%
1
25%
4
133.3%
0
0%
5. Secondary Outcome
Title Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable post-CYP17 inhibitor patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 expanded dose level (phase 1 + phase 2)
Measure Participants 15 17 1 15
Number [participants]
0
0%
3
42.9%
0
0%
1
25%
6. Secondary Outcome
Title Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Description 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.
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable Chemotherapy-naïve and CYP17i-naïve patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 600mg/Day ODM-201 1400mg/Day ODM-201 1800mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 expanded dose level (phase 1 + phase 2) Phase 1
Measure Participants 9 9 2 2 2
RECIST response CR+PR
1
25%
4
57.1%
0
0%
1
25%
0
0%
RECIST response CR+PR+SD
9
225%
6
85.7%
2
66.7%
2
50%
2
66.7%
7. Secondary Outcome
Title Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Description 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.
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable Post-chemotherapy and CYP17i-naïve patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201 1800mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 expanded dose level (phase 1 + phase 2) Phase 1
Measure Participants 8 7 1 5 1
RECIST response CR+PR
1
25%
0
0%
0
0%
1
25%
0
0%
RECIST response CR+PR+SD
5
125%
3
42.9%
0
0%
4
100%
1
33.3%
8. Secondary Outcome
Title Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Description 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.
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable Post-CYP17i patients
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 1400mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2)
Measure Participants 13 12 9
RECIST response CR+PR
0
0%
2
28.6%
0
0%
RECIST response CR+PR+SD
5
125%
9
128.6%
6
200%
9. Secondary Outcome
Title Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201 1800mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 expanded dose level (phase 1 + phase 2) Phase 1
Measure Participants 11 10 1 7 1
Number [participants]
10
250%
7
100%
1
33.3%
6
150%
1
33.3%
10. Secondary Outcome
Title Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 600mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 Phase 1 expanded dose level (phase 1 + phase 2)
Measure Participants 9 7 1 1 10
Number [participants]
5
125%
4
57.1%
1
33.3%
0
0%
7
233.3%
11. Secondary Outcome
Title Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Description 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
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
Evaluable post-CYP17i patients with bone metastasis at baseline
Arm/Group Title 200mg/Day ODM-201 400mg/Day ODM-201 1000mg/Day ODM-201 1400mg/Day ODM-201
Arm/Group Description expanded dose level (phase 1 + phase 2) expanded dose level (phase 1 + phase 2) Phase 1 expanded dose level (phase 1 + phase 2)
Measure Participants 11 15 1 11
Number [participants]
5
125%
9
128.6%
1
33.3%
6
150%
12. Secondary Outcome
Title Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
Description AUC(0-8h)
Time Frame Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Outcome Measure Data

Analysis Population Description
PK population (Day 8)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 3 7 3 3 3 3
Mean (Standard Deviation) [h*ng/mL]
6387.27
(742.01)
10973.66
(5939.78)
14205.99
(2127.26)
14817.39
(4190.48)
31764.82
(8714.06)
28884.44
(4900.60)
13. Secondary Outcome
Title Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Description
Time Frame Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Outcome Measure Data

Analysis Population Description
PK population (Day 8)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 3 7 3 3 3 3
Mean (Standard Deviation) [ng/mL]
1011.67
(168.84)
1757.57
(858.72)
2033.00
(277.59)
2392.33
(406.63)
4459.00
(1163.10)
4235.00
(617.80)
14. Secondary Outcome
Title Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Description
Time Frame 1 day

Outcome Measure Data

Analysis Population Description
PK population (Day 1)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 4 7 3 4 3 3
Median (Standard Deviation) [h]
3.00
(1.63)
3.00
(0.73)
3.00
(0.92)
5.08
(1.47)
3.00
(1.15)
5.00
(1.51)
15. Secondary Outcome
Title Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
Description AUC(0-8h)
Time Frame Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Outcome Measure Data

Analysis Population Description
PK population (Day 8)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 3 7 3 3 3 3
Mean (Standard Deviation) [h*ng/mL]
11754.23
(5161.80)
15501.56
(2755.85)
24902.56
(12129.79)
29980.83
(11658.75)
63531.81
(15798.30)
64435.97
(22930.30)
16. Secondary Outcome
Title Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Description
Time Frame Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Outcome Measure Data

Analysis Population Description
PK population (Day 8)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 3 7 3 3 3 3
Mean (Standard Deviation) [ng/mL]
1850.00
(654.83)
2491.43
(328.86)
3963.33
(1935.21)
4643.33
(1340.01)
9336.67
(2054.27)
9406.67
(3165.38)
17. Secondary Outcome
Title Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Description
Time Frame 1 day

Outcome Measure Data

Analysis Population Description
PK population (Day 1)
Arm/Group Title 200 mg/Day ODM-201 400 mg/Day ODM-201 600 mg/Day ODM-201 1000 mg/Day ODM-201 1400 mg/Day ODM-201 1800 mg/Day ODM-201
Arm/Group Description Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Phase 1
Measure Participants 4 7 3 4 3 3
Median (Standard Deviation) [h]
3.00
(1.63)
1.52
(1.33)
3.00
(0.92)
5.04
(2.05)
3.00
(1.15)
5.00
(0.55)

Adverse Events

Time Frame 3 months
Adverse Event Reporting Description Phase 1 dose escalation and Phase 2 per dose
Arm/Group Title Phase 1, 200mg/Day ODM-201 Phase 1, 400mg/Day ODM-201 Phase 1, 600mg/Day ODM-201 Phase 1, 1000mg/Day ODM-201 Phase 1, 1400mg/Day ODM-201 Phase 1, 1800mg/Day ODM-201 Phase 2, 200mg/Day ODM-201 Phase 2, 400mg/Day ODM-201 Phase 2, 1400mg/Day ODM-201
Arm/Group Description Dose escalation Dose escalation Dose escalation Dose escalation Dose escalation Dose escalation Dose expansion Dose expansion Dose expansion
All Cause Mortality
Phase 1, 200mg/Day ODM-201 Phase 1, 400mg/Day ODM-201 Phase 1, 600mg/Day ODM-201 Phase 1, 1000mg/Day ODM-201 Phase 1, 1400mg/Day ODM-201 Phase 1, 1800mg/Day ODM-201 Phase 2, 200mg/Day ODM-201 Phase 2, 400mg/Day ODM-201 Phase 2, 1400mg/Day ODM-201
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Phase 1, 200mg/Day ODM-201 Phase 1, 400mg/Day ODM-201 Phase 1, 600mg/Day ODM-201 Phase 1, 1000mg/Day ODM-201 Phase 1, 1400mg/Day ODM-201 Phase 1, 1800mg/Day ODM-201 Phase 2, 200mg/Day ODM-201 Phase 2, 400mg/Day ODM-201 Phase 2, 1400mg/Day ODM-201
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/4 (0%) 2/7 (28.6%) 0/3 (0%) 1/4 (25%) 1/3 (33.3%) 0/3 (0%) 2/38 (5.3%) 3/37 (8.1%) 4/35 (11.4%)
Blood and lymphatic system disorders
Anaemia 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Cardiac disorders
Cardiac failure 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Gastrointestinal disorders
Colitis ulcerative 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
General disorders
Fatigue 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
General physical health deterioration 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Infections and infestations
Bacteraemia 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Diverticulitis 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Liver abscess 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Pneumonia 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Staphylococcal infection 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Injury, poisoning and procedural complications
Hand fracture 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Laceration 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Muscle injury 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Musculoskeletal and connective tissue disorders
Back pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 1/35 (2.9%)
Bone pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Nervous system disorders
Cerebral ischaemia 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Renal and urinary disorders
Urinary retention 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Vascular disorders
Lymphoedema 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Other (Not Including Serious) Adverse Events
Phase 1, 200mg/Day ODM-201 Phase 1, 400mg/Day ODM-201 Phase 1, 600mg/Day ODM-201 Phase 1, 1000mg/Day ODM-201 Phase 1, 1400mg/Day ODM-201 Phase 1, 1800mg/Day ODM-201 Phase 2, 200mg/Day ODM-201 Phase 2, 400mg/Day ODM-201 Phase 2, 1400mg/Day ODM-201
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/4 (100%) 5/7 (71.4%) 2/3 (66.7%) 4/4 (100%) 3/3 (100%) 2/3 (66.7%) 33/38 (86.8%) 35/37 (94.6%) 27/35 (77.1%)
Blood and lymphatic system disorders
Anaemia 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 3/38 (7.9%) 4/37 (10.8%) 1/35 (2.9%)
Ear and labyrinth disorders
Motion sickness 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Eye disorders
Eye pruritus 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Visual acuity reduced 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Gastrointestinal disorders
Constipation 1/4 (25%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 5/38 (13.2%) 6/37 (16.2%) 2/35 (5.7%)
Diarrhoea 3/4 (75%) 1/7 (14.3%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 2/3 (66.7%) 0/38 (0%) 4/37 (10.8%) 1/35 (2.9%)
Nausea 1/4 (25%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 4/38 (10.5%) 4/37 (10.8%) 3/35 (8.6%)
Flatulence 0/4 (0%) 0/7 (0%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Stomatitis 2/4 (50%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Vomiting 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 3/37 (8.1%) 3/35 (8.6%)
Abdominal distension 0/4 (0%) 0/7 (0%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 0/35 (0%)
Abdominal pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Dry mouth 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Dysphagia 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
General disorders
Fatigue 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 1/3 (33.3%) 1/3 (33.3%) 7/38 (18.4%) 8/37 (21.6%) 5/35 (14.3%)
Oedema peripheral 2/4 (50%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 2/38 (5.3%) 0/37 (0%) 4/35 (11.4%)
Pain 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 3/38 (7.9%) 5/37 (13.5%) 4/35 (11.4%)
Asthenia 2/4 (50%) 2/7 (28.6%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Chest pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 3/37 (8.1%) 2/35 (5.7%)
Influenza like illness 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 2/37 (5.4%) 0/35 (0%)
Pyrexia 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Infections and infestations
Influenza 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 2/35 (5.7%)
Urinary tract infection 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 2/37 (5.4%) 0/35 (0%)
Bronchitis 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Nasopharyngitis 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 1/38 (2.6%) 1/37 (2.7%) 1/35 (2.9%)
Oral herpes 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Tinea cruris 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Viral infection 0/4 (0%) 0/7 (0%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Injury, poisoning and procedural complications
Fall 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/38 (5.3%) 0/37 (0%) 2/35 (5.7%)
Infusion related reaction 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Sunburn 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Investigations
Weight decreased 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 5/35 (14.3%)
Blood alkaline phosphatase increased 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 0/35 (0%)
Cardiac murmur 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Urine output increased 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Metabolism and nutrition disorders
Decreased appetite 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 3/38 (7.9%) 3/37 (8.1%) 5/35 (14.3%)
Hyperkalaemia 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 3/38 (7.9%) 4/37 (10.8%) 2/35 (5.7%)
Back pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 5/38 (13.2%) 6/37 (16.2%) 4/35 (11.4%)
Musculoskeletal pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 4/38 (10.5%) 2/37 (5.4%) 3/35 (8.6%)
Bone pain 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 2/37 (5.4%) 2/35 (5.7%)
Muscle spasms 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Muscular weakness 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/38 (5.3%) 1/37 (2.7%) 3/35 (8.6%)
Myalgia 2/4 (50%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Pain in extremity 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 4/35 (11.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 1/37 (2.7%) 1/35 (2.9%)
Meningioma 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Nervous system disorders
Headache 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 1/4 (25%) 1/3 (33.3%) 1/3 (33.3%) 1/38 (2.6%) 0/37 (0%) 1/35 (2.9%)
Dizziness 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/38 (0%) 1/37 (2.7%) 1/35 (2.9%)
Hypoaesthesia 0/4 (0%) 1/7 (14.3%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Presyncope 0/4 (0%) 0/7 (0%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Sciatica 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Somnolence 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 1/35 (2.9%)
Psychiatric disorders
Insomnia 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/38 (5.3%) 4/37 (10.8%) 2/35 (5.7%)
Renal and urinary disorders
Haematuria 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 3/38 (7.9%) 0/37 (0%) 0/35 (0%)
Urinary incontinence 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 0/37 (0%) 0/35 (0%)
Reproductive system and breast disorders
Gynaecomastia 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 2/3 (66.7%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 0/35 (0%)
Erectile dysfunction 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 1/3 (33.3%) 0/3 (0%) 0/38 (0%) 2/37 (5.4%) 0/35 (0%)
Dyspnoea 1/4 (25%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 2/37 (5.4%) 0/35 (0%)
Epistaxis 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/38 (0%) 1/37 (2.7%) 1/35 (2.9%)
Skin and subcutaneous tissue disorders
Rash 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 2/35 (5.7%)
Dry skin 1/4 (25%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Erythema 0/4 (0%) 0/7 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/38 (0%) 0/37 (0%) 0/35 (0%)
Vascular disorders
Hot flush 0/4 (0%) 0/7 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 2/38 (5.3%) 4/37 (10.8%) 2/35 (5.7%)
Hypertension 0/4 (0%) 0/7 (0%) 1/3 (33.3%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/38 (2.6%) 1/37 (2.7%) 1/35 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/Title Head of Oncology
Organization Orion Pharma, Development, R&D
Phone +358 10 4261
Email mika.mustonen@orionpharma.com
Responsible Party:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01317641
Other Study ID Numbers:
  • 3104001
First Posted:
Mar 17, 2011
Last Update Posted:
Mar 29, 2017
Last Verified:
Feb 1, 2017