Safety and Pharmacokinetics of ODM-209 (STESIDES)

Orion Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Castration-resistant Prostate Cancer

Prostate Cancer Metastatic

Metastatic Breast Cancer

Advanced Breast Cancer

Treatments

Drug: ODM-209

Study type

Interventional

Funder types

Industry

Identifiers

NCT03878823

3125001

Details and patient eligibility

About

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

Full 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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.