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

NCT ID: NCT02979366

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2020-05-11

Brief Summary

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.

Conditions

Acute Myeloid Leukaemia (AML); Myelodysplastic Syndrome (MDS)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S64315 (also referred as MIK665) administered once a week

Group Type: EXPERIMENTAL

S64315 once a week

Intervention Type: DRUG

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.

S64315 (also referred as MIK665) administered twice a week

Group Type: EXPERIMENTAL

S64315 twice a week

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

MIK665; MIK665

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR, a Servier Group company

INDUSTRY

Sponsor Role: collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew WEI

Role: PRINCIPAL_INVESTIGATOR

The Alfred Hospital, Melbourne, Victoria

Locations

Patient Care Location: Smilow Cancer Hospital at Yale

New Haven, Connecticut, United States

The University of Texas MD Anderson Cancer Center, Department of Leukemia, Division of Cancer Medicine

Houston, Texas, United States

The Alfred Hospital Department of Haematology

Melbourne, , Australia

Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service

Melbourne, , Australia

Institut Paoli-Calmettes Departement d'Hématologie

Marseille, , France

Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire

Paris, , France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, , France

Hospital Universitario Vall d' Hebron/VHIO Hematology Department

Barcelona, , Spain

Hospital Universitario La Fe Hematology Department

Valencia, , Spain

Countries

United States; Australia; France; Spain

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Study-level clinical trial data

View Document

Other Identifiers

2016-003768-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

136541

Identifier Type: OTHER

Identifier Source: secondary_id

CL1-64315-001

Identifier Type: -

Identifier Source: org_study_id