Description:
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Clinical Trials /
Safety and Pharmacokinetics of ODM-209
NCT03878823
Related Conditions:
- Breast Carcinoma
- Prostate Adenocarcinoma
Recruiting Status:
Recruiting
Phase:
Phase 1/Phase 2
Trial Eligibility
Document
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID: 3125001
- NCT ID: NCT03878823
Conditions
- Prostate Cancer Metastatic
- Advanced Breast Cancer
- Castration-resistant Prostate Cancer
- Metastatic Breast Cancer
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| ODM-209 | ODM-209 Part 1 Dose escalation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| ODM-209 Part 1 Dose escalation | Experimental |
| |
| ODM-209 Part 2 Dose expansion | Experimental |
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Maximum tolerated dose (MTD) |
| Time Frame: | Within first 28 days of treatment |
| Safety Issue: | |
| Description: | Highest dose level at which under 33% of patients in a cohort experience DLT |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Orion Corporation, Orion Pharma |
Trial Keywords
- metastatic castration-resistant prostate cancer
- advanced hormone receptor positive breast cancer
Last Updated
July 22, 2020
