- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509039
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Study Overview
Detailed Description
This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the safety, tolerability, (Pharmacokinetics) PK, and preliminary efficacy of CC-122 in Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL).
Subjects will receive ascending dose levels of CC-122 from Cycle 1 onwards to measure PK and to determine safety and tolerability.
An initial cohort of at least three subjects will be given CC-122 at a dose of 2.0 mg on an intermittent dosing schedule (5 continuous days out of 7 days per week) and 3-6 subjects will be enrolled in subsequent dose levels. Dose escalation for subsequent cohorts will proceed according to a standard dose escalation design (3+3 design) (Storer, 1989) to establish initial toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tokyo
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Koto-ku, Tokyo, Japan, 1358550
- Local Institution - 002
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CC-122
CC-122 is administered orally, on a 5 continuous days out of 7 days per week intermittent dosing schedule.
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5 continuous days out of 7 days per week intermittent dosing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicities (DLTs)
Time Frame: Up to 2 weeks
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Number of participants with a DLT
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Up to 2 weeks
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Maximum Tolerated Dose (MTD)
Time Frame: Up to 4weeks
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The last dose level with 0 or 1 out of 6 subjects experiencing Dose Limiting Toxicities (DLTs) during the DLT evaluation period.
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Up to 4weeks
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Adverse Events (AEs)
Time Frame: Apprximately 6 months
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Number of participants with adverse events
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Apprximately 6 months
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Pharmacokinetics -AUC
Time Frame: Apprximately 2 weeks
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Area under the plasma concentration time-curve
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Apprximately 2 weeks
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Pharmacokinetics - Cmax
Time Frame: Apprximately 2 weeks
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Peak (maximum) plasma concentration
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Apprximately 2 weeks
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Pharmacokinetics - t1/2
Time Frame: Apprximately 2 weeks
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Terminal half-life of (t1/2)
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Apprximately 2 weeks
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Pharmacokinetics - Tmax
Time Frame: Apprximately 2 weeks
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Time to maximum plasma concentration (Tmax).
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Apprximately 2 weeks
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Pharmacokinetics - CL/F
Time Frame: Apprximately 2 weeks
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Apparent clearance
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Apprximately 2 weeks
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Pharmacokinetics - Vz/F
Time Frame: Apprximately 2 weeks
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Apparent volume of distribution
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Apprximately 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antitumor activity
Time Frame: Apprximately 6 months
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Antitumor efficacy, determined by response rates in each tumor type using appropriate tumor response criteria, and duration of response
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Apprximately 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC-122-ST-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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