A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
Lymphoma, Non-Hodgkin
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring CC-122, Phase1, solid tumor, non-Hodgkin's lymphom
Eligibility Criteria
Inclusion Criteria:
- Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted
- 20 years or older, with histological or cytological confirmation of advanced solid tumors or Non-Hodgkin's Lymphoma (NHL), including those who have progressed on standard anticancer therapy or for whom no other conventional therapy exists
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 for all tumors
Subjects must have the following laboratory values:
・Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin (Hgb) ≥ 9 g/dL, drawn at least 7 days after the last RBC transfusion
- Platelets (Plt) ≥ 100 x 109/L, drawn at least 7 days after the last platelet transfusion
- Potassium within normal limits or correctable with supplements
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver tumors are present
- Serum bilirubin ≤ 1.5 x ULN; subjects with serum bilirubin >1.5 x ULN and ≤ 2 x ULN may be enrolled if agreed to by the sponsor
- Serum creatinine ≤ ULN or 24-hour clearance ≥ 50 mL/min
- Negative serum pregnancy test in females of childbearing potential as per the CC-122 Pregnancy Prevention Rist Management Plan
- Able to adhere to the study visit schedule and other protocol requirements
- Must adhere to the Pregnancy Prevention Rist Management Plan
Exclusion Criteria:
- Subjects with primary central nervous system (CNS) malignancies or symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed
- Known acute or chronic pancreatitis
- Any peripheral neuropathy ≥ NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade 2
- Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Left Ventricular Ejection Fraction (LVEF) < 45% as determined by Multiple Gated Acquisition Scan (MUGA) scan or Echocardiogram (ECHO)
Complete left bundle branch, or bifascicular block
- Congenital long QT syndrome
- Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation
- QTcF > 460 msec on screening electrocardiogram (ECG) (mean of triplicate recordings)
- Unstable angina pectoris or myocardial infarction ≤ 3 months prior to starting CC-122
- Troponin-T value >0.4 ng/mL or Brain Natriuretic Peptide (BNP) >300 pg/mL Subjects with baseline troponin-T >ULN or BNP >100 pg/mL are eligible but must and optimization of cardioprotective therapy.
- Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting CC-122 or who have not recovered from side effects of such therapy. Luteinizing hormone-releasing hormone (LHRH) agonists will be allowed for subjects with metastatic prostate cancer
- Major surgery ≤ 2 weeks prior to starting CC-122 or still recovering from post operative side effects
- Women who are pregnant or breast feeding. Adults of reproductive potential not employing two forms of birth control as per Pregnancy Prevention Risk Management Plan (PPRMP)
- Known human immunodeficiency virus (HIV) infection
- Known acute or chronic hepatitis B or C virus infection
- Status post solid organ transplant
Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogeneic HSCT, or if otherwise not fully recovered from HSCT-related toxicity
a. The 6-month exclusionary period for recovery from HSCT-associated toxicity, applies regardless of whether an autologous or allogeneic transplant was performed
- Known hypersensitivity to any component of the formulation of CC-122
- Any significant medical condition (including active or controlled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition that confounds the ability to interpret data from the study
Sites / Locations
- Local Institution - 002
Arms of the Study
Arm 1
Experimental
CC-122
CC-122 is administered orally, on a 5 continuous days out of 7 days per week intermittent dosing schedule.