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ODM-207 in Patients With Advance Solid Tumours (BETIDES)

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: NCT03035591
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE January 20, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE December 22, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Maximum Tolerated Dose [ Time Frame: 28 days ]
Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03035591 on ClinicalTrials.gov Archive Site
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 ODM-207 in Patients With Advance Solid Tumours
Official Title  ICMJE Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
Brief Summary This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: ODM-207
Study Arms  ICMJE Experimental: ODM-207
Escalating doses of ODM-207
Intervention: Drug: ODM-207
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 21, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
144
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
  • Life expectancy >12 weeks
  • Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
  • ECOG performance status of 0 to 1

Exclusion Criteria:

  • History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
  • Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
  • History of or current leptomeningeal or brain metastasis or spinal cord compression.
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 Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035591
Other Study ID Numbers  ICMJE 3121001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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
Principal Investigator: Johann De Bono ICR/Royal Marsden
PRS Account Orion Corporation, Orion Pharma
Verification Date January 2019

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