Aller au contenu
Trouver des essais cliniques
Accueil » Trouver des essais cliniques » Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Partager Imprimer
Code de protocole Servier: CL1-64315-004 Sponsor: Institut de Recherches Internationales Servier Identifiant Clinicaltrials.gov: NCT04629443 Numéro EudraCT: 2019-004896-38

Trouver un site de recrutement

Comment participer à l'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 7 centres

Description de l'étude

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.
Titre officiel: Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)
Indications
Acute Myeloid Leukaemia
Interventions / Traitements
  • S 64315 (also referred as MIK665) and azacitidine
Autres numéros d'identification
  • CL1-64315-004

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexes

Homme/Femme

Accepte les volontaires en bonne santé

Non

  • 1. Patients aged ≥ 18 years
  • 2. Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French American-British M3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to MyeloDysplastic Syndrome and without established alternative therapy or, newly diagnosed AML, not previously treated for AML and who are not candidate for intensive chemotherapy due to age or comorbidities.
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • 4. Adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first Investigational Medicinal Product administration.

  • 1. Previous myeloproliferative syndrome (MPS).
  • 2. Patients previously treated with any Mcl-1 inhibitor.
  • 3. Patients who have not recovered from toxicity of previous anticancer therapy, including Grade ≥ 2 toxicity (except alopecia of any grade) according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 5.0, prior to the first IMP administration.
  • 4. Severe or uncontrolled active acute or chronic infection.
  • 5. Uncontrolled hepatitis B or C infection.
  • 6. Known carriers of HIV antibodies, history of significant liver disease, active acute or chronic pancreatitis, active central nervous system disease.
  • 7. Troponin > ULN (Upper Limit of reference range) or Troponin T > ULN if Troponin I cannot be assessed.
  • 8. Clinically significant cardiac dysfunction (including New York Heart Association class ≥II heart failure, Left Ventricular Ejection Fraction (LVEF) < 50% as assessed by echocardiography (ECHO) or Multi-Gated Acquisition (MUGA) scan).
  • 9. QT prolongation defined as QTc (QT interval corrected for heart rate) interval (corrected with Fridericia's formula) > 450 ms for males and > 470 ms for females, obtained from triplicate 12-lead ECG.
  • 10. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
  • 11. Uncontrolled arterial hypertension (systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure (DBP) > 95 mmHg).

Comment l'étude est-elle conçue ?

Allocation
N/A
Modèle d'étude interventionnelle
Groupe unique
Groupe de participants / Bras de traitement
Expérimental: S64315 (also referred as MIK665) with azacitidine
Intervention / Traitement
Traitement: S 64315 (also referred as MIK665) and azacitidine
The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.

Mots clés

Fournis par Servier
Acute Myeloid Leukaemia Oncology Mcl-1 inhibitor Azacitidine Combination Phase I/II International Safety Maximum tolerated dose
Autres termes
Leukemia, Myeloid, Acute Neoplasms