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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

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ClinicalTrials.gov Identifier: NCT02848001
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment Phase
Leukemia, Myeloid, Acute Myelodysplastic Syndromes Drug: CC-90009 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 14, 2016
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : June 21, 2021


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848001


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

Locations
United States, California
City of Hope Not yet recruiting
Duarte, California, United States, 91010-301
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
United States, Illinois
Northwestern Memorial Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Canada, Ontario
Princess Margaret Hospital University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
France
Institut Paoli Calmettes Not yet recruiting
Marseille Cedex 9, France, 13273
Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie Not yet recruiting
Villejuif, France, 94800
Italy
Spedali Civili Di Brescia Not yet recruiting
Brescia, Italy, 25123
A.O. Ospedale Ca Granda - Niguarda Not yet recruiting
Milano, Italy, 20162
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway, N-5053
Oslo University Hospital, Rikshospitalet HF Not yet recruiting
Oslo, Norway, N-0027
Spain
H Clinic I Provincial Not yet recruiting
Barcelona, Spain, 08036
Hospital Clinico Universitario de Salamanca Not yet recruiting
Salamanca, Spain, 37007
Hosptial La Fe Not yet recruiting
Valencia, Spain, 46009
United Kingdom
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow Scotland, United Kingdom, G12 OXL
The Churchill Hospital Not yet recruiting
Oxford, United Kingdom, 0X3 7LE
Sponsors and Collaborators
Celgene
Investigators
Study Director: Michael Pourdehnad, MD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02848001     History of Changes
Other Study ID Numbers: CC-90009-AML-001
2017-001535-39 ( EudraCT Number )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

Keywords provided by Celgene:
CC-90009
Hematologic Cancers
Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
AML
MDS

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Syndrome
Leukemia
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions