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Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

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Code de protocole Servier: CL1-55746-001 Sponsor: Institut de Recherches Internationales Servier Identifiant Clinicaltrials.gov: NCT02920697 Numéro EudraCT: 2013-003779-36

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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 18 centres

Description de l'étude

The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.
Titre officiel: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Indications
Chronic Lymphocytic Leukaemia (CLL) B-Cell Non-Hodgkin Lymphoma (NHL) Multiple Myeloma (MM)
Interventions / Traitements
  • S 55746
Autres numéros d'identification
  • CL1-55746-001

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

  • * Women or men aged >/=18 years
  • * Patients with a measurable histologically confirmed Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Small Lymphocytic Lymphoma (SLL) and Marginal Zone Lymphoma (MZL) (Arm A), or patients with an evaluable immunophenotypically confirmed CLL (Arm B), or patients with a measurable Multiple Myeloma t(11;14) (arm A expansion part) according to International Myeloma Working Group (IMWG) criteria
  • * Relapsed after or refractory disease to standard treatments, and require treatment in the opinion of the investigator
  • * Estimated life expectancy > 12 weeks
  • * World Health Organization (WHO) performance status 0-2
  • * Adequate bone marrow, renal and hepatic functions
  • * No evidence or treatment for another malignancy within 2 years prior to study entry. Curatively treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia is allowed

  • * B-cell NHL patients at low risk of tumour lysis syndrome (TLS)
  • * Recent/concomitant treatment altering gastric pH
  • * Previous treatment with a BH3 mimetic
  • * Previous therapy for the studied disease within 3 weeks before first intake
  • * Radioimmunotherapy, radiotherapy within 8 weeks before first intake
  • * Major surgery within 3 weeks before first day of study drug dosing
  • * Corticosteroids >= 20 mg prednisone equivalent per day within 7 days before first intake
  • * Anticoagulant oral drugs, aspirin > 325 mg/day within 7 days prior to first S 55746 intake
  • * Positive direct antiglobulin test (Coombs test) and haptoglobin below normal value
  • * Prior allogenic stem cell transplant
  • * Autologous stem cell transplant within 3 months before first intake
  • * NHL patients diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukaemia
  • * Human immunodeficiency virus (HIV)
  • * Known acute or chronic hepatitis B or hepatitis C
  • * Impaired cardiac function
  • * Medications known to prolong corrected QT (QTc) interval
  • * History or/ clinically suspicious for cancer- related Central Nervous System disease
  • * Solitary extramedullary plasmacytoma
  • * Laboratory Signs of TLS
  • * Strong or moderate CYP3A4 inhibitors/inducers (treatment, food or drink products)
  • * Treatment highly metabolized by the CYP3A4 or CYP2D6 and/or substrates with a narrow therapeutic index, multienzyme and/or OATP and/or P-gp substrates or herbal products.
  • * Known hypersensitivity to rasburicase
  • * Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolytic anaemia
  • * Patients receiving proton pump inhibitor

Comment l'étude est-elle conçue ?

Allocation
Non randomisé
Modèle d'étude interventionnelle
Groupe unique
Groupe de participants / Bras de traitement
Expérimental: B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)
Intervention / Traitement
Traitement: S 55746
S 55746, per os administration, from 50 to 1500 mg, once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met.
Groupe de participants / Bras de traitement
Expérimental: Chronic Lymphocytic Leukaemia (CLL)
Intervention / Traitement
Traitement: S 55746
S 55746, per os administration, from 50 to 1500 mg, once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met.

Mots clés

Autres termes
Leukemia, B-Cell Lymphoma, B-Cell Multiple Myeloma