Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Pharmacokinetics of ODM-209 (STESIDES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878823
Recruitment Status : Active, not recruiting
First Posted : March 18, 2019
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date January 18, 2022
Actual Study Start Date  ICMJE April 17, 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Maximum tolerated dose (MTD) [ Time Frame: Within first 28 days of treatment ]
Highest dose level at which under 33% of patients in a cohort experience DLT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics of ODM-209
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer Metastatic
  • Advanced Breast Cancer
  • Castration-resistant Prostate Cancer
  • Metastatic Breast Cancer
Intervention  ICMJE Drug: ODM-209
co-administered with glucocorticoid and mineralocorticoid, orally daily
Study Arms  ICMJE
  • Experimental: ODM-209 Part 1 Dose escalation
    Intervention: Drug: ODM-209
  • Experimental: ODM-209 Part 2 Dose expansion
    Intervention: Drug: ODM-209
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2022)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
256
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   France,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878823
Other Study ID Numbers  ICMJE 3125001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jutta Hänninen Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP