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A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

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ClinicalTrials.gov Identifier: NCT02367196
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in subjects advanced, refractory solid and hematologic cancers.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: CC-90002 Drug: Rituximab Phase 1

Detailed Description:

CC-90002-ST-001 is an open-label, Phase 1, dose escalation and expansion, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers.

The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002.

Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab and expansion in combination with rituximab in subjects with CD20-positive NHL.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers
Actual Study Start Date : March 12, 2015
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Part A: CC-90002
CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
Drug: CC-90002
Experimental: Part B: CC-90002 with Rituximab
CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
Drug: CC-90002
Drug: Rituximab



Primary Outcome Measures :
  1. Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to 18 months ]
    Number of participants with a DLT

  2. Non-Tolerated Dose (NTD) - Part A [ Time Frame: Up to 18 months ]
    Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

  3. Maximum Tolerated Dose (MTD) - Part A [ Time Frame: Up to 18 months ]
    Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

  4. Non-Tolerated Dose (NTD) - Part B [ Time Frame: Up to 24 months ]
    Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

  5. Maximum Tolerated Dose (MTD) - Part B [ Time Frame: Up to 24 months ]
    Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.


Secondary Outcome Measures :
  1. Antitumor efficacy [ Time Frame: Up to 36 months ]
    Determined by response rates of each tumor type using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and other tumor-appropriate response criteria.

  2. Pharmacokinetics ‐ Cmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Maximum observed concentration in serum

  3. Pharmacokinetics - AUC [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Area under the serum concentration - time curve

  4. Pharmacokinetics - tmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Time to peak (maximum) serum concentration

  5. Pharmacokinetics ‐ T1/2 [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Terminal half‐life (T1/2)

  6. Pharmacokinetics - CL [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Total body clearance of the drug from serum

  7. Pharmacokinetics - Vmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Volume of distribution at steady-state

  8. Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Determine the presence and frequency of anti-drug antibodies

  9. Overall Survival - Part B [ Time Frame: Up to 2 years ]
    Measured as the time from the first dose of CC-90002 to death due to any cause.

  10. Progression-free survival- Part B [ Time Frame: Up to 2 years ]
    Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause



Information from the National Library of Medicine

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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 or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
  2. At least one site of measurable disease in subjects with solid tumors and NHL.
  3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
  5. Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab

Exclusion Criteria:

  1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
  2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
  3. Symptomatic central nervous system involvement.
  4. Impaired cardiac function or clinically significant cardiac disease.
  5. Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
  6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
  7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
  8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
  9. Major surgery ≤ 2 weeks prior to starting CC-90002.
  10. Pregnant or nursing females.
  11. Known HIV infection.
  12. Known chronic, active 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.

concurrent second cancers requiring active, ongoing systemic treatment.


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): NCT02367196


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

Locations
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United States, Arizona
Scottsdale Healthcare Research Institute Completed
Scottsdale, Arizona, United States, 85258
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520-8073
United States, Georgia
Northside Hospital, Inc Not yet recruiting
Atlanta, Georgia, United States, 30342
United States, Texas
South Texas Accelerated Research Therapeutics Completed
San Antonio, Texas, United States, 78229
United States, Wisconsin
Medical College of WI Froedtert Multi-Disciplinary Cancer Clinic Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Germany
University of Cologne Not yet recruiting
Cologne, Germany, D-50937
Universitaetsklinikum Muenster Not yet recruiting
Muenster, Germany, 48149
University Hospital of Ulm Not yet recruiting
Ulm, Germany, 89081
Italy
ASST Spedali Civili P.O. di Brescia Not yet recruiting
Brescia, Italy, 25123
ASST Grande Ospedale Metropolitano Niguarda, Milano Not yet recruiting
Milano, Italy, 20162
Polyclinic San Matteo IRCCS Not yet recruiting
Pavia, Italy, 27100
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Not yet recruiting
Torino, Italy, 10126
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti Recruiting
Badalona (Barcelona), Spain, 08916
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Duran i Reynals Institut Catala d'Oncologia Recruiting
Barcelona, Spain, 08907
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Clinico Virgen de la Victoria Not yet recruiting
Málaga, Spain, 29010
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Marques de Valdecilla Recruiting
Santander, Spain, 39008
Hospital de la Fe Recruiting
Valencia, Spain, 46009
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Michael Burgess, MD, PhD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02367196     History of Changes
Other Study ID Numbers: CC-90002-ST-001
2015-000101-39 ( EudraCT Number )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by Celgene:
CC-90002
Monoclonal
Antibody
CD47
Advanced
Solid Cancers
Hematologic Cancers
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antirheumatic Agents