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Accueil » Trouver des essais cliniques » Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

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

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Code de protocole Servier: CL1-64315-001 Sponsor: Institut de Recherches Internationales Servier Identifiant Clinicaltrials.gov: NCT02979366 Numéro EudraCT: 2016-003768-38

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Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
critères d'éligibilité
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
Nom: Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone: +33 1 55 72 60 00
L'étude a 9 centres

Description de l'étude

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.
Titre officiel: Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)
Indications
Acute Myeloid Leukaemia (AML) Myelodysplastic Syndrome (MDS)
Interventions / Traitements
  • S64315 once a week
  • S64315 twice a week
Autres numéros d'identification
  • CL1-64315-001

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexe

Homme/Femme

Accepte les volontaires en bonne santé

Non

  • * 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.

  • * 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.

Comment l'étude est-elle conçue ?

Allocation
Non randomisé
Modèle d'étude interventionnelle
Groupe unique
Groupe de participants / Bras de traitement
Expérimental: S64315 (also referred as MIK665) administered once a week
Intervention / Traitement
Traitement: S64315 once a week
S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours once every week (21- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.
Groupe de participants / Bras de traitement
Expérimental: S64315 (also referred as MIK665) administered twice a week
Intervention / Traitement
Traitement: S64315 twice a week
S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours twice every week (28- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.

Mots clés

Autres termes
Leukemia, Myeloid, Acute Myelodysplastic Syndromes