Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

Conditions

Prostate Cancer

Brief summary

A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.

Robert H. Jones, Karim Fizazi, Nicholas D. James, Teuvo L.J. Tammela, Nobuaki Matsubara et al. (18 authors)

The Journal of Urology2022-04-07

10.1097/ju.0000000000002570.13

Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer.

Egils Vjaters, Karim Fizazi, Nicholas D. James, Teuvo L.J. Tammela, Nobuaki Matsubara et al. (17 authors)

Journal of Clinical Oncology2022-02-161 citations

10.1200/jco.2022.40.6_suppl.090

Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment

Christian Zurth, Pirjo Nykänen, Gary Wilkinson, Päivi Taavitsainen, Annamari Vuorela et al. (8 authors)

Clinical Pharmacokinetics2021-12-0613 citations

10.1007/s40262-021-01078-y

Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials.

Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K.

2017-02-1425 citations

10.1016/j.euf.2017.01.015

PD32-08 SYNERGISTIC ANTICANCER EFFECT OF COMBINATION TREATMENT WITH MEK INHIBITOR AND PI3K /MTOR DUAL INHIBITOR IN CASTRATION-RESISTANT PROSTATE CANCER IN VIVO AND EX VIVO

Se‐Young Choi, Jaeyoon Jung, Jae Hyeon Han, Jung Hyun Shin, Jeong-Woen Moon et al. (9 authors)

The Journal of Urology2016-03-282 citations

10.1016/j.juro.2016.02.684

PD32-06 LONG-TERM SAFETY AND ANTITUMOR ACTIVITY OF ODM-201 IN CHEMOTHERAPY AND CYP17-INHIBITOR NAÏVE PATIENTS FROM THE ARADES AND THE ARAFOR TRIALS

Neal D. Shore, Teuvo L.J. Tammela, Christophe Massard, Petri Bono, John Aspegrén et al. (7 authors)

The Journal of Urology2016-03-28

10.1016/j.juro.2016.02.682

A study of two ODM-201 formulations with a safety and tolerability extension phase in patients with metastatic chemotherapy-naive castration-resistant prostate cancer (CRPC).

Christophe Massard, Teuvo L.J. Tammela, Egils Vjaters, V. Lietuvietis, Petri Bono et al. (10 authors)

Journal of Clinical Oncology2014-02-015 citations

10.1200/jco.2014.32.4_suppl.115

Interventions

DRUGODM-201 Tablet A

Tablet A formulation of ODM-201

DRUGODM-201 Tablet B

Tablet B formulation of ODM-201

DRUGODM-201 capsule formulation

Capsule formulation of ODM-201

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Written informed consent (IC) obtained. * Histologically confirmed adenocarcinoma of prostate * Progressive metastatic disease * Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy * Adequate bone marrow, hepatic and renal function * Able to swallow the ODM-201 whole as a capsule or tablet.

Exclusion criteria

* Previous chemotherapy for prostate cancer. * Known metastases in the brain. * History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin. * Known gastrointestinal condition that can significantly affect the absorption of the study treatment.

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve (AUC) of ODM-201	0-48 hrs	The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Cmax of ODM-201	0-48 hrs	The plasma peak concentration.

Secondary

Measure	Time frame	Description
Terminal elimination rate constant of ODM-201	0-48 hrs	The terminal elimination rate constant from log-linear portion of a concentration-time curve.
Terminal elimination half-life of ODM-201	0-48 hrs	The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
tmax of ODM-201	0-48 hrs	The time to reach peak concentration.

Countries

Latvia

Outcome results

None listed