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Clinical Trials/EUCTR2013-002447-29-GB
EUCTR2013-002447-29-GBActive, not recruitingPhase 1

A phase I study of Human Pharmacokinetics and Safety of ORY-1001, and LSD1 inhibitor, in relapsed or refractory acute leukaemia (AL) - A Phase I study of Human Pharmacokinetics and Safety of ORY-1001

Oryzon Genomics S.A.0 sites30 target enrollmentStarted: November 26, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patients aged 16 and above.
  • •2. Patients must have relapsed or refractory AL (exluding promyelocytic leukaemia) considered by the investigator ineligible for intensive chemotherapy regimen at that time
  • •3. Patients must have ECOG Performance Status (PS) of 0-2
  • •4. Women of child-bearing potential must have negative serum or urine pregnancy test within two weeks prior treatment start
  • •5. Fertile male or female patients must use highly efficient contraception for the duration of the study and 6 months after the last ORY-1001 dose.
  • •6. Male patients must use condoms to avoid drug exposure of their partner.
  • •7. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent
  • •8. Life expectancy of at least 2 months
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 2
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 8
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

  • •1. Cancer history that according to the investigator might confound the assessment of the study endpoints
  • •2. Patients with uncontrolled hypertension or diabetes, hepatitis or HIV.
  • •3. Inter-current illness or social situation that will limit compliance with study requirements
  • •4. Pregnancy or lactating / breast feeding
  • •5. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities if entered into the clinical study
  • •6. Acute myeloid leukaemia treatment within the previous 14 days. Hydroxyurea or 6-mercaptopurine are allowed until 12 hours prior study treatment start and after the first treatment block (day 1-5) in case of hyperleucocytosis.
  • •7. Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: Tranylcypromine or Phenelzine.
  • •8. Radiotherapy less than 2 weeks prior to the start of the study

Investigators

Sponsor
Oryzon Genomics S.A.

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