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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

Brief Summary:
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ODM-207 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : December 22, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: ODM-207
Escalating doses of ODM-207
Drug: ODM-207



Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 28 days ]
    Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035591


Locations
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Finland
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Johann De Bono ICR/Royal Marsden

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03035591     History of Changes
Other Study ID Numbers: 3121001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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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
Additional relevant MeSH terms:
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Neoplasms