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

O

Orion Pharma

Status and phase

Completed
Phase 2
Phase 1

Conditions

Solid Tumors

Treatments

Drug: ODM-207

Study type

Interventional

Funder types

Industry

Identifiers

NCT03035591
3121001

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

ODM-207
Experimental group
Description:
Escalating doses of ODM-207
Treatment:
Drug: ODM-207

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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