A study to establish the pharmacokinetics (how the human body processes the drug) and safety of a new anti-cancer drug, ORY-1001 in cancer of blood and bone marrow after treatment or remissio

Phase 1

Conditions: Refractory or Relapsed acute leukaemia (AL)
MedDRA version: 16.1Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: LLTClassification code 10024330Term: Leukemia acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: PTClassification code 10000830Term: Acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-002447-29-ES

Lead Sponsor: Oryzon Genomics S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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