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

Completed · Phase 1

Conditions studied: Hematologic Neoplasms

In brief

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

Key facts

Study ID

NCT02367196

Run by

Celgene

People needed

60

Starts

2015-03-12

Expected to finish

2020-12-24

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• At least one site of measurable disease in subjects with solid tumors and NHL.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
• 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

You may not qualify if…

• High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
• High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
• Symptomatic central nervous system involvement.
• Impaired cardiac function or clinically significant cardiac disease.
• Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
• Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
• Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
• Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
• Major surgery ≤ 2 weeks prior to starting CC-90002.
• Pregnant or nursing females.
• Known HIV infection.
• Known chronic, active hepatitis B or C (HBV/HCV) infection.
• Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
• History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
• History of concurrent second cancers requiring active, ongoing systemic treatment.
• concurrent second cancers requiring active, ongoing systemic treatment.

Where it is running

• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• University of California San Francisco — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Hospital Universitari Germans Trias i Pujol Can Ruti — Badalona (Barcelona), Spain
• Hospital Val d'Hebron — Barcelona, Spain
• Duran i Reynals Institut Catala d'Oncologia — Barcelona, Spain
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
• Hospital 12 de Octubre — Madrid, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain
• Hospital Marques de Valdecilla — Santander, Spain
• Hospital de la Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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