Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT03672695
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myeloid Leukaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S 64315 (also referred as MIK665) and venetoclax — COMBINATION_PRODUCT
    The treatment combination period can only begin after the planned dose of venetoclax is reached. Depending on the administration dosing schedule, the combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) during which the patient continues to receive venetoclax daily. Once the planned dose of both drugs is reached the schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen for venetoclax. S64315 should be administered 2 to 4 hours after venetoclax intake, via IV infusion. The dose escalation will start at 50 mg once a week and doses up to 250 mg once a week might be explored. Venetoclax will be administered orally once a day. The dose escalation will start at 100 mg daily and doses up to 600 mg daily might be explored. Venetoclax must be taken with a meal (ideally during breakfast) in order to avoid reduced efficacy.

Study Details

The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

Key Dates

Start date
Nov 28, 2018
Status verified
Feb 2024
Primary completion
Nov 12, 2022
Completion
May 30, 2023

Study Design

Enrollment
37 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Schedule - S64315 low dose and venetoclax high dose administered in combination
  • Experimental: Initial Schedule - S64315 medium dose and venetoclax low dose administered in combination
  • Experimental: Initial Schedule - S64315 medium dose and venetoclax medium dose administered in combination
  • Experimental: Initial Schedule - S64315 medium dose and venetoclax high dose administered in combination
  • Experimental: Initial Schedule - S64315 high dose and venetoclax medium dose administered in combination
  • Experimental: Alternative Schedule - Venetoclax medium dose administered with no S64315
  • Experimental: Alternative Schedule - S64315 medium dose and venetoclax medium dose administered in combination
  • Experimental: Alternative Schedule - S64315 high dose and venetoclax low dose administered in combination

Primary Outcome Measure

Incidence of Dose Limiting Toxicity (DLTs) [ Time Frame: At the end of cycle 1 (each cycle is 21 or 28 days). ]

Locations (2)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital at YaleNew HavenConnecticut06511-
The University of Texas MD Anderson Cancer Center, Houston, TXHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Smilow Cancer Hospital at Yale· New Haven, CTThe University of Texas MD Anderson Cancer Center, Houston, TX· Houston, TX

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