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OpenTrials
Completed

NCT Number: NCT03035591

ODM-207 in Patients With Advance Solid Tumours

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

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Helsinki University Central Hospital, Department of Oncology

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ODM-207

Drug

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 28 days

    Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study 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

Acronym: BETIDES

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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