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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):

February 13, 2015
February 20, 2015
October 2, 2017
March 12, 2015
June 13, 2019   (Final data collection date for primary outcome measure)
  • Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to 18 months ]
    Number of participants with a DLT
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of participants with a Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to 18 months ]
  • Non-Tolerated Dose (NTD) [ 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.
  • Maximum Tolerated Dose (MTD) [ 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.
Complete list of historical versions of study NCT02367196 on ClinicalTrials.gov Archive Site
  • 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.
  • Pharmacokinetics ‐ Cmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Maximum observed concentration in serum
  • Pharmacokinetics - AUC [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Area under the serum concentration - time curve
  • Pharmacokinetics - tmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Time to peak (maximum) serum concentration
  • Pharmacokinetics ‐ T1/2 [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Terminal half‐life (T1/2)
  • Pharmacokinetics - CL [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Total body clearance of the drug from serum
  • Pharmacokinetics - Vmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Volume of distribution at steady-state
  • Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 and beyond; and after discontinuation ]
    Determine the presence and frequency of anti-drug antibodies
  • 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.
  • 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
  • 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.
  • Pharmacokinetics ‐ Cmax [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Maximum observed concentration in plasma
  • Pharmacokinetics - AUC [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Area under the plasma concentration‐time curve
  • Pharmacokinetics - tmax [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Time to peak (maximum) plasma concentration
  • Pharmacokinetics ‐ T1/2 [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Terminal half‐life (T1/2)
  • Pharmacokinetics - CL [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Total body clearance of the drug from the plasma
  • Pharmacokinetics - Vmax [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Volume of distribution at steady-state
  • Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 Days 1, 8, 15, 22; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]
    Determine the presence and frequency of anti-drug antibodies
Not Provided
Not Provided
 
A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
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
CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in subjects advanced, refractory solid and hematologic cancers.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hematologic Neoplasms
  • Drug: CC-90002
  • Drug: Rituximab
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)
Interventions:
  • Drug: CC-90002
  • Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
June 13, 2019
June 13, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Spain,   United States
 
 
NCT02367196
CC-90002-ST-001
2015-000101-39 ( EudraCT Number )
Yes
Not Provided
Not Provided
Celgene
Celgene
Not Provided
Study Director: Michael Burgess, MD, PhD Celgene
Celgene
September 2017

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