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

  • Clinicaltrials.gov identifier

    NCT02848001

  • Recruitment Status

    Recruiting

  • First Posted

    July 28, 2016

  • Last update posted

    June 10, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Leukemia, Myeloid, Acute
    Myelodysplastic Syndromes
  • Intervention/Treatment: Drug: CC-90009
  • Phase: Phase 1

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 110 participants
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: November 2016
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: February 2022

Arms and interventions

Arm Intervention/treatment
Experimental: CC-90009 - Part A
Will be administered intravenously per dosing schedule in a 28-day cycle.
Drug: CC-90009
CC-90009
Experimental: CC-90009 - Part B - AML and MDS patients
Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
Drug: CC-90009
CC-90009

Outcome Measures

  • Primary Outcome Measures: 1. Dose- limiting toxicity (DLT) [ Time Frame: Up to 42 days ]
    Number of participants with a DLT
  • 2. Non-tolerated dose (NTD) [ Time Frame: Up to 42 days ]
    Dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1 during dose escalation.
  • 3. Maximum tolerated dose (MTD) [ Time Frame: Up to 42 days ]
    Last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT in Cycle 1 during dose escalation
  • Secondary Outcome Measures: 1. Pharmacokinetics-Cmax [ Time Frame: Up to Day 11 ]
    Maximum observed concentration in plasma
  • 2. Pharmacokinetics - AUC24 [ Time Frame: Up to Day 11 ]
    Area under the plasma concentration time-curve from time 0 to 24 hours
  • 3. Pharmacokinetics - tmax [ Time Frame: Up to Day 11 ]
    Time to peak (maximum) plasma concentration
  • 4. Pharmacokinetics - t 1/2 [ Time Frame: Up to Day 11 ]
    terminal half-life
  • 5. Pharmacokinetics - CL [ Time Frame: Up to Day 11 ]
    Total body clearance of the drug from plasma
  • 6. Pharmacokinetics - Vss [ Time Frame: Up to Day 11 ]
    Volume of distribution at steady-state
  • 7. Preliminary efficacy of CC-90009 [ Time Frame: Up to 2.5 years ]
    Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)
  • 8. Preliminary efficacy of CC-90009 - AML [ Time Frame: Up to 2.5 years ]
    Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML.
  • 9. Preliminary efficacy of CC-90009 - MDS [ Time Frame: Up to 2.5 years ]
    Determined by myelodysplastic syndrome (MDS) response rate based on the International Working Group (IWG) response criteria for Myelodysplasia.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

United States, Connecticut
Yale Cancer Center
New Haven

United States, Illinois
Northwestern Memorial
Chicago

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Missouri
Washington University Siteman Cancer Center
Saint Louis

United States, New Jersey
Hackensack University Medical Center
Hackensack

Canada, Ontario
Princess Margaret Hospital University Health Network
Toronto

France
Institut Paoli Calmettes
Marseille Cedex 9

France
Hopital Lyon Sud
Pierre Benite

France
Institut Claudiu Regaud, IUCT-Oncopole
Toulouse

France
Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie
Villejuif

Norway
Haukeland University Hospital
Bergen

Norway
Oslo University Hospital, Rikshospitalet HF
Oslo

Spain
Hospital Germans Trias I Pujol
Badalona

Spain
H Clinic I Provincial
Barcelona

Spain
MD Anderson Cancer Center - Madrid
Madrid

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Hospital Clinico Universitario de Salamanca
Salamanca

Spain
Hosptial La Fe
Valencia

United Kingdom
Clatterbridge Cancer Centre - Liverpool
Liverpool

United Kingdom
The Churchill Hospital
Oxford

Sponsors and Collaborators

Celgene

Investigators

Study Director: Michael Pourdehnad, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02848001 History of Changes
  • Other Study ID Numbers: CC-90009-AML-001, 2017-001535-39
  • First Posted: July 28, 2016 Key Record Dates
  • Last Update Posted: June 10, 2021
  • Last Verified: June 2021
  • Keywords provided by Celgene: CC-90009
    Hematologic Cancers
    Leukemia
    Acute Myeloid Leukemia
    Myelodysplastic Syndrome
    AML
    MDS
  • Additional relevant MeSH terms: Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome