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A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT02641002
Recruitment Status : Terminated (Preliminary monotherapy data in relapsed/refractory AML and high-risk MDS did not offer a sufficiently encouraging profile for further dose escalation/expansion)
First Posted : December 29, 2015
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE November 12, 2015
First Posted Date  ICMJE December 29, 2015
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Dose-limiting Toxicity (DLT) [ Time Frame: Up to 26 months ]
    Number of participants with a DLT
  • Non-tolerated Dose (NTD) [ Time Frame: Up to 26 months ]
    The NTD is defined as the dose at which 2 or more of up to 6 evaluable subjects in a cohort experience a DLT in Cycle 1
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 26 months ]
    The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Preliminary Efficacy of CC-90002 [ Time Frame: Up to 35 months ]
    Determined by response rates of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) by disease-appropriate response criteria.
  • Pharmacokinetics-Cmax [ Time Frame: Up to 35 months ]
    Maximum observed concentration in serum
  • Pharmacokinetics-AUC [ Time Frame: Up to 35 months ]
    Area under the serum concentration - time curve
  • Pharmacokinetics-Tmax [ Time Frame: Up to 35 months ]
    Time to peak (maximum) serum concentration
  • Pharmacokinetics-T 1/2 [ Time Frame: Up to 35 months ]
    Terminal half-life (T 1/2)
  • Pharmacokinetics- CL [ Time Frame: Up to 35 months ]
    Total body clearance of the drug from the serum
  • Pharmacokinetics- Vss [ Time Frame: Up to 35 months ]
    Volume of distribution at steady-state
  • Anti-Drug Antibodies (ADAs) [ Time Frame: Up to 35 months ]
    Determine the presence and frequency of anti-drug antibodies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Official Title  ICMJE A Phase 1, Open-label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Acute Myeloid Leukemia and High-Risk Myelodsplastic Syndrome
Brief Summary

Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B.

The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.

Detailed Description In both Part A and Part B, treatments will be administered in two phases starting with an induction phase followed by a maintenance phase. During the induction phase, treatments will be administered in 42-day cycles in Cycles 1 through 4. Following completion of Cycle 4 in the induction phase, subjects with non-progressive disease will enter the maintenance phase. During the maintenance phase, treatments will be administered in 28 day cycles. Subjects may continue CC-90002 for up to a maximum of 2 years (eg, induction phase Cycles 1 through 4 and maintenance phase Cycles 5 through 24) or until clinically significant disease progression, the occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90002, whichever comes first.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
Intervention  ICMJE Drug: CC-90002
Monoclonal Ab to CD47
Study Arms  ICMJE Experimental: Dose escalation of CC-90002
CC-90002 by intravenous (IV) infusion on a 28 day cycle
Intervention: Drug: CC-90002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2015)
78
Actual Study Completion Date  ICMJE July 18, 2018
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ≥ 18 years of age, at the time of signing the informed consent form (ICF).
  2. Relapsed and/or primary refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with subtype refractory anemia with excess blasts (RAEB)-2 defined as high or very high-risk that is recurrent or refractory, or the patient is intolerant to established therapy.
  3. Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
  4. Subject consents to serial bone marrow aspiration and biopsies as specified.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
  6. Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
  7. Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and for up to 8 weeks following the last dose of CC 90002.

Exclusion Criteria:

  1. Active central nervous system (CNS) leukemia or known CNS leukemia.
  2. Immediately life-threatening, severe complications of leukemia.
  3. Impaired cardiac function or clinically significant cardiac diseases.
  4. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  5. Prior autologous hematopoietic stem cell transplant ≤ 3 months.
  6. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months.
  7. Systemic immunosuppressive therapy post HSCT or with clinically significant graft-versus-host disease (GVHD).
  8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks whichever is shorter.
  9. Major surgery ≤ 2 weeks and recovered from any clinically significant effects of recent surgery.
  10. Pregnant or nursing females.
  11. Known HIV infection.
  12. Known chronic hepatitis B or C (HBV/HCV) infection.
  13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  15. History of concurrent second cancers requiring active, ongoing systemic treatment.
  16. Subjects for whom potentially curative anticancer therapy is available.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02641002
Other Study ID Numbers  ICMJE CC-90002-AML-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Burgess, MD, PhD Celgene Corporation
PRS Account Celgene
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP