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Trial record 2 of 11 for:    cd47

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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Celgene
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02641002
First received: November 12, 2015
Last updated: May 23, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Leukemia, Myeloid, Acute Myelodysplastic Syndromes Drug: CC-90002 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 71
Actual Study Start Date: March 1, 2016
Estimated Study Completion Date: July 10, 2019
Estimated Primary Completion Date: July 10, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation of CC-90002
CC-90002 by intravenous (IV) infusion on a 28 day cycle
Drug: CC-90002
Monoclonal Ab to CD47

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02641002

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

Locations
United States, Arizona
Mayo Clinic Phoenix Recruiting
Phoenix, Arizona, United States, 85054
United States, California
UCLA Division of Hematology Oncology Recruiting
Los Angeles, California, United States, 90095-1752
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Celgene
Investigators
Study Director: Michael Burgess, MD, PhD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02641002     History of Changes
Other Study ID Numbers: CC-90002-AML-001
Study First Received: November 12, 2015
Last Updated: May 23, 2017

Keywords provided by Celgene:
CC-90002
Monoclonal
Antibody
CD47
Hematologic Cancers
Acute Myeloid Leukemia
AML
Myelodysplastic syndrome
MDS
Blood disorder

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

ClinicalTrials.gov processed this record on July 21, 2017