Clinical Trials /

Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)

NCT03564288

Description:

This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are unresponsive to currently available therapies. Eligible participants will receive cycles of treatment involving IV infusion of SKI-G-801 daily for 14 days followed by 14 days off. Treatment cycles will be repeated until progressive disease or unacceptable toxicity.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)
  • Official Title: A Phase 1 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: OSCO-P1301
  • NCT ID: NCT03564288

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
SKI-G-801Dose Escalation Cohort

Purpose

This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are unresponsive to currently available therapies. Eligible participants will receive cycles of treatment involving IV infusion of SKI-G-801 daily for 14 days followed by 14 days off. Treatment cycles will be repeated until progressive disease or unacceptable toxicity.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation CohortExperimentalTo identify the recommended phase 2 dose (RP2D) of SKI-G-801 in patients with relapsed or refractory AML (Acute Myeloid Leukemia)
  • SKI-G-801

Eligibility Criteria

        Inclusion Criteria:

          -  Willing and able to provide written informed consent for participation, prior to
             completing any study-related procedures.

          -  Diagnosis of Acute Myeloid Leukemia (AML)

          -  Patients must have been off previous antileukemia therapy for at least 2 weeks or 5
             half-lives, whichever is longer if the immediate prior regimen included only weekly
             chemotherapy; or 4 weeks or 5 half-lives, whichever is longer, from any therapy with
             therapeutic biologics and from any type of investigational therapy. Daily hydroxyurea
             for up to 2 weeks to keep the absolute blast count below 50 x 10⁹/L will be allowed,
             but must be discontinued 24 hours prior to administration of study drug. Hydroxyurea
             will be permitted during the first cycle of treatment if necessary.

          -  At least one prior induction regimen (with or without consolidation) which may have
             included hematopoietic stem cell transplantation (HSCT).

          -  Have adequate liver function.

          -  Have adequate renal (kidney) function.

          -  Female patients must either be of non-childbearing potential, or, if of childbearing
             potential, have a negative urine pregnancy test at screening and agree not to try to
             become pregnant during the study and for 45 days after the final study drug
             administration. Women of childbearing potential, if heterosexually active, must agree
             to use 2 forms of highly effective birth control as determined by the protocol,
             starting at screening, throughout the study period and for 45 days after the final
             study drug administration.

          -  Female patients must agree not to breastfeed at screening, throughout the study period
             and for 45 days after the final study drug administration.

          -  Male patients with female spouse/partner of childbearing potential, must agree to use
             2 forms of highly effective birth control as determined by the protocol, starting at
             screening, throughout the study period and for 45 days after the final study drug
             administration.

        Exclusion Criteria:

          -  Patient has a diagnosis of Acute Promyelocytic Leukemia (APL) or chronic myelogenous
             leukemia in blast crisis.

          -  If patient is post allogenic transplant and requires therapy for graft vs host disease
             (GVHD) within 14 days prior to date of screening.

          -  Requires treatment with concomitant drugs that prolong QT/QTc interval.

          -  Recent history of cardiac ischemic disease (acute myocardial infarction within 6
             months; uncontrolled angina); severe uncontrolled ventricular arrhythmia; recent
             transient ischemic attack or stroke within 6 months of screening; poorly controlled
             hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm
             Hg).

          -  Patient has active, untreated central nervous system (CNS) disease.

        Other protocol defined inclusion/exclusion criteria could apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended phase 2 dose (RP2D)
Time Frame:From Cycle 1, Day 1 until disease progression, unacceptable toxicity, patient withdrawal from study, or judged not to be in patient's interest to continue in study, assessed up to 36 months
Safety Issue:
Description:RP2D of SKI-G-801 determined using Neuenschwander's continual reassessment method (N-CRM)

Secondary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 30 days following last dose of study drug
Safety Issue:
Description:Number, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v4.03), seriousness and relatedness to treatment of treatment-emergent AEs
Measure:Number of participants with clinical laboratory abnormalities
Time Frame:Up to 30 days following last dose of study drug
Safety Issue:
Description:
Measure:Number of participants with overall safety profiles
Time Frame:Up to 30 days following last dose of study drug
Safety Issue:
Description:
Measure:Number of participants with electrocardiogram (ECG) abnormalities
Time Frame:Up to 30 days following last dose of study drug
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Oscotec Inc.

Last Updated

October 25, 2019