Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

Servier

Status and phase

Completed

Phase 1

Conditions

Myelodysplastic Syndrome (MDS)

Acute Myeloid Leukaemia (AML)

Treatments

Drug: S64315 twice a week

Drug: S64315 once a week

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02979366

136541 (Other Identifier)

2016-003768-38 (EudraCT Number)

CL1-64315-001

Details and patient eligibility

About

The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged ≥ 18 years;
Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):
- with relapsed or refractory disease without established alternative therapy or
- secondary to MDS treated at least by hypomethylating agent or
- > 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative chemotherapy Or Patients with cytologically confirmed and documented MDS), in relapse or refractory after previous treatment line including at least one hypomethylating agent and have ≥10% bone marrow blasts;
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Circulating white blood cells < 10^9 /L (with or without use of hydroxycarbamide).
Adequate renal function defined as:

• Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) > 50 mL/min/1.73m2.
LDH < 2 x ULN
Adequate hepatic function defined as:
- AST and ALT ≤ 1.5 x ULN
- Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum CK/CPK ≤2.5 x ULN.

Exclusion criteria

Unlikely to cooperate in the study.
Participant already enrolled in the study who has received at least one S64315 infusion.
Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
Participation in another interventional study requiring investigational treatment intake within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of S64315 (participation in non-interventional registries or epidemiological studies is allowed).
Presence of ≥ CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03)
Unresolved ≥ CTCAE grade 2 diarrhoea or medical conditions associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease)
Known carriers of HIV antibodies
Known history of significant liver disease
Uncontrolled hepatitis B or C infection
Known active or chronic pancreatitis
History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.