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Home » Find Clinical Trials » Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

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

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Servier Protocol Code: CL1-64315-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03672695 EudraCT Number: 2018-001809-88

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 7 locations

Study description

This study was done to test a new anticancer drug, S64315, combined with another anticancer drug, venetoclax, in participants with Acute Myeloid Leukaemia (AML).

AML is a cancer of the blood and bone marrow. In AML, the cancer cells have higher amounts of certain proteins. These proteins are Mcl1 (myeloid cell leukaemia 1) and Bcl-2 (B-cell lymphoma-2). They protect cancer cells from destruction by the body’s defence system.

S64315 is a drug that blocks Mcl-1 proteins.

In this study, S64315 was combined with another drug called venetoclax (study drugs). Venetoclax is already approved for the treatment of AML in combination with other drugs. Venetoclax blocks Bcl-2 proteins. It was hoped that by combining S64315 and venetoclax their actions on the cancer cells may be more effective.

The main objectives of this study were:

  • To look at the safety of S64315 in patients when given in combination with venetoclax.
  • To find the highest dose of S64315 and venetoclax that participants could take without too much risk (highest tolerated dose). This highest tolerated dose helps to find the recommended dose (the one that is both safe and effective for patients).
Official title: An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).
Results
English (USA)
Français (France)
English (USA)
Conditions
Acute Myeloid Leukaemia
Interventions / Treatments
  • S 64315 (also referred as MIK665) and venetoclax
Other study id numbers
  • CL1-64315-002

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have AML that:
    • returned after improvement (relapsed) or did not respond to any treatment (refractory),

or

    • was secondary to a condition called myelodysplastic syndrome which means the bone marrow does not make enough healthy blood cells,

or

    • Be aged 65 years or older, were too frail to support intensive treatment and had not previously been treated for AML.

Participants could not take part in the study if they:

  • Had received anticancer treatment with medicine or radiation within two weeks before starting the study.
  • Had a cancer other than AML.

How is the study designed?

Allocation
Randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Initial Schedule - S64315 low dose and venetoclax high dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Initial Schedule - S64315 medium dose and venetoclax low dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Initial Schedule - S64315 medium dose and venetoclax medium dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Initial Schedule - S64315 medium dose and venetoclax high dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Initial Schedule - S64315 high dose and venetoclax medium dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Alternative Schedule - Venetoclax medium dose given with no S64315
Intervention / Treatment
Drug: Venetoclax

Venetoclax was given as tablets taken orally once a day.

Participant Group / Arm
Experimental: Alternative Schedule - S64315 medium dose and venetoclax medium dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Participant Group / Arm
Experimental: Alternative Schedule - S64315 high dose and venetoclax low dose given in combination
Intervention / Treatment
Combination Product: S64315 (also referred as MIK665) and venetoclax

S64315 was given through infusion (injection given slowly) into a vein. Infusion time was about 30 minutes (and up to 3 hours if clinically indicated). Venetoclax was given as tablets taken orally. Participants took a combination of S64315 once a week and venetoclax once a day.

Keywords

Additional Relevant MeSH Terms Glioma
Leukemia, Myeloid, Acute