Clinical trial NCT03878823: Safety and Pharmacokinetics of ODM-209
Official title: Safety and Pharmacokinetics of ODM-209 in Patients With Metastatic Castration-resistant Prostate Cancer or Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Metastatic
Advanced Breast Cancer
Castration-resistant Prostate Cancer
Metastatic Breast Cancer
Keywords: metastatic castration-resistant prostate cancer
advanced hormone receptor positive breast cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.

Detailed description: Part 1: to evaluate the safety and tolerability of ODM-209, to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible, to define the recommended dose of ODM-209 and replacement therapy for Part 2 of the study.

Part 2: to further evaluate the safety and tolerability of ODM-209, to evaluate the preliminary anticancer activity of ODM-209.

Eligibility criteria: MAIN INCLUSION CRITERIA:

* Written informed consent (IC) obtained.
* Age ≥ 18 years.
* ECOG performance status 0-1.
* Adequate marrow, liver and kidney function.
* Able to swallow study treatment.

Main Prostate cancer specific inclusion criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Castration resistant prostate cancer with serum testosterone \< 50 ng/dl.
* Metastatic disease.
* Ongoing androgen deprivation therapy with GnRH analogue, or have had bilateral orchiectomy.
* Have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy.

Main Breast cancer specific inclusion criteria:

* Histologically confirmed breast carcinoma
* ER positive, HER2-negative advanced breast cancer
* Postmenopausal or pre/perimenopausal if amendable to be treated with GnRH agonist or antagonist.
* Documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor.

MAIN EXCLUSION CRITERIA

* History of pituitary dysfunction.
* Known brain metastases or active leptomeningeal disease.
* Active infection or other medical condition that would make corticosteroids contraindicated.
* Hypotension or uncontrolled hypertension.
* Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (New York Heart Association \[NYHA\] class II-IV).
* Prolonged QTcF interval.
* Use of any investigational drug 4 weeks prior to the start of the study treatment.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Within first 28 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University Hospital of Copenhagen
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Jutta Hänninen
role: STUDY_DIRECTOR
References: