Clinical Trials /

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

NCT02848001

Description:

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk myelodysplastic syndrome.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
  • Official Title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Clinical Trial IDs

  • ORG STUDY ID: CC-90009-AML-001
  • SECONDARY ID: 2017-001535-39
  • NCT ID: NCT02848001

Conditions

  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
CC-90009CC-90009 - Part A

Purpose

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk myelodysplastic syndrome.

Detailed Description

      Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion,
      first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute
      myeloid leukemia (AML) and relapsed or refractory high-risk myelodysplastic syndrome.

      The dose escalation part (Part A) of the study will evaluate the safety and tolerability of
      escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B),
      will further evaluate the safety and efficacy of CC-90009 administered at or below the
      maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in
      order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or
      refractory AML and relapsed or refractory high-risk myelodysplastic syndrome.
    

Trial Arms

NameTypeDescriptionInterventions
CC-90009 - Part AExperimentalWill be administered intravenously per dosing schedule in a 28-day cycle.
  • CC-90009
CC-90009 - Part B - AML and MDS patientsExperimentalRelapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
  • CC-90009

Eligibility Criteria

        Inclusion Criteria:

          1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent
             Document).

          2. Subject must understand and voluntarily sign an ICD prior to any study-related
             assessments/procedures being conducted.

          3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or
             refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World
             Health Organization criteria who are not suitable for other established therapies.

          4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.

          5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI)
             without conditioning.

          6. Subjects must have the following screening laboratory values:

               -  Total White Blood Cell count (WBC) < 25 x 109/L prior to first infusion. Prior or
                  concurrent treatment with hydroxyurea to achieve this level is allowed.

               -  Selected electrolytes within normal limits or correctable with supplements.

               -  Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).

               -  Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault
                  equation.

          7. Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP)

        Exclusion Criteria:

          1. Subjects with acute promyelocytic leukemia (APL)

          2. Subjects with clinical symptoms suggesting active central nervous system (CNS)
             leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if
             there is clinical suspicion of CNS involvement by leukemia during screening.

          3. Patients with prior autologous hematopoietic stem cell transplant who, in the
             investigator's judgment, have not fully recovered from the effects of the last
             transplant (e.g., transplant related side effects).

          4. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or
             reduced intensity conditioning ≤ 6 months prior to starting CC-90009.

          5. Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or
             with clinically significant graft-versus-host disease (GVHD). The use of topical
             steroids for ongoing skin or ocular GVHD is permitted.

          6. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives
             or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to
             control peripheral leukemia blasts.

          7. Leukapheresis ≤ 2 weeks prior to starting CC-90009.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose- limiting toxicity (DLT)
Time Frame:Up to 42 days
Safety Issue:
Description:Number of participants with a DLT

Secondary Outcome Measures

Measure:Pharmacokinetics-Cmax
Time Frame:Up to Day 11
Safety Issue:
Description:Maximum observed concentration in plasma
Measure:Pharmacokinetics - AUC24
Time Frame:Up to Day 11
Safety Issue:
Description:Area under the plasma concentration time-curve from time 0 to 24 hours
Measure:Pharmacokinetics - tmax
Time Frame:Up to Day 11
Safety Issue:
Description:Time to peak (maximum) plasma concentration
Measure:Pharmacokinetics - t 1/2
Time Frame:Up to Day 11
Safety Issue:
Description:terminal half-life
Measure:Pharmacokinetics - CL
Time Frame:Up to Day 11
Safety Issue:
Description:Total body clearance of the drug from plasma
Measure:Pharmacokinetics - Vss
Time Frame:Up to Day 11
Safety Issue:
Description:Volume of distribution at steady-state
Measure:Preliminary efficacy of CC-90009
Time Frame:Up to 2.5 years
Safety Issue:
Description:Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)
Measure:Preliminary efficacy of CC-90009 - AML
Time Frame:Up to 2.5 years
Safety Issue:
Description:Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML.
Measure:Preliminary efficacy of CC-90009 - MDS
Time Frame:Up to 2.5 years
Safety Issue:
Description:Determined by myelodysplastic syndrome (MDS) response rate based on the International Working Group (IWG) response criteria for Myelodysplasia.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celgene

Trial Keywords

  • CC-90009
  • Hematologic Cancers
  • Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • AML
  • MDS

Last Updated

December 2, 2019