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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 : October 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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. Following completion of Part A, CC-90002 in combination with rituximab will be administered in subjects with CD20-positive non-Hodgkin's lymphoma (NHL) in Part B dose escalation and expansion phase.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group 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 : June 13, 2019
Estimated Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

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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 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 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.
  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 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.
Contacts and Locations

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

Locations
United States, Arizona
Scottsdale Healthcare Research Institute Recruiting
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, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti Recruiting
Badalona (Barcelona), Spain, 08916
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Sponsors and Collaborators
Celgene
Investigators
Study Director: Michael Burgess, MD, PhD Celgene
More Information

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: October 2, 2017
Last Verified: September 2017

Keywords provided by Celgene:
CC-90002
Monoclonal
Antibody
CD47
Advanced
Solid Cancers
Hematologic Cancers

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents