Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma, Lymphoma, Large B-Cell, Diffuse, Pleiotropic Pathway Modifier, Glioblastoma, Lymphoma, Primary Central Nervous System Lymphoma

In brief

The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.

Key facts

Study ID: NCT01421524
Run by: Celgene
People needed: 271
Starts: 2011-09-12
Expected to finish: 2023-11-21
Last updated by the study team: 2023-12-12

Who can join

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

You may qualify if…

Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Men and women, 18 years or older, with histologically or cytologically-confirmed, advanced solid tumors, Non-Hodgkin Lymphona (NHL), Multiple Myloma (MM), or advanced unresectable solid tumors limited to the tumor types below.
Subjects who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no standard anticancer therapy exists. Must have disease that is objectively measurable
Measurable disease criteria:
Subjects with Glioblastoma multiforme (GBM) do not have to have objectively measurable disease at entry.
For MM, Diffuse large B-cell lymphoma (DLBCL): Subjects must have disease that is objectively measurable, measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g excreted in a 24-hour collection sample) for MM and measurable disease by Internatonal Working Group (IWG) for NHL (with at least one measurable lesion's longest diameter ≥ 2cm).
For Primary Central Nervous System (CNS) Lymphoma (PCNSL): Subjects must have disease that is objectively measurable by International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary CNS Lymphoma, Cerebrospinal Fluid (CSF) cytology (in case of leptomeningeal only disease), or vitreal aspiration cytology and/or retinal photographs (in case of ocular lymphoma).
Tumor specific inclusion criteria:
DLBCL-2 cohort:
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
Histologically proven diffuse large B-cell non-Hodgkin's lymphoma
Must have progressed following or have been unable to tolerate at least one prior anthracycline or alkylating agent containing regimen (with or without anti-CD20).
Platelets ≥ 60 x 109/L.
For PCNSL cohort:
ECOG Performance Status of ≤ 2
Recurrent/refractory CNS non-Hodgkin's lymphoma involving CNS (Brain, Cerebrospinal fluid (CSF) or intraocular compartments)
Stable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the 96 hours prior to initiation of therapy.
ECOG Performance Status of ≤ 2.
For glioblastoma multiforme (GBM-2) cohort:
ECOG Performance Status of ≤ 2
Primary GBM or gliosarcoma
ECOG Performance Status of ≤ 2.
Has received prior treatment including radiation and chemotherapy, with radiation completed > 12 weeks prior to Day 1 (or ≥ 4 weeks if the recurrence is outside of the prior radiation field).
Progression of disease after last therapy demonstrated by RANO criteria
No prior therapy with Avastin

You may not qualify if…

History of other carcinomas within the last 5 years except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current Prostate-specific antigen (PSA) of <1.0 mg/dL on 2 evaluations at least 3 months apart; the most recent evaluation must be no more than 4 weeks prior to Day 1 of the study drug, or other malignancies that were completely resected or treated Stage 1/2 lesions currently in complete remission.
Symptomatic central nervous system metastases (excluding Glioblastoma multiforrme (GBM) and Primary Central Nervous System Lymphoma (PCNSL). Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed.
Known symptomatic acute or chronic pancreatitis.
Any peripheral neuropathy ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 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 multigated acquisition (MUGA) scan or echocardiography (ECHO).
Complete left bundle branch, or bifasicular block.
Congenital long QT syndrome.
Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
QTcF > 460 msec on screening Electrocardiography (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 BNP >300 pg/mL.
° Subjects with baseline troponin-T >Upper Limit of Normal (ULN) or B-type Natriuretic Peptide (BNP) >100 pg/mL are eligible but must have cardiologist evaluation prior to enrollment in the trial for baseline assessment 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).
Other concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection or renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.
Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy.
Major surgery ≤ 2 weeks prior to starting study drug 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.
Known Human immunodeficiency virus (HIV) infection.
Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with Hepatocellular carcinoma (HCC).
Status post solid organ transplant.
Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogenic HSCT or either transplant type, if otherwise not fully recovered from HSCT related toxicity.
For MM-2 cohort only: Hypersensitivity (eg, Rash Grade 3 or 4) to thalidomide, lenalidomide, or dexamethasone (MM-2b).
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Where it is running

City of Hope Cancer Center — Duarte, California, United States
UCLA Neuro-Oncology Program — Los Angeles, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States
University Of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
Comprehensive Cancer Centers Of Nevada — Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey University — New Brunswick, New Jersey, United States
Mount Sinai Hospital — New York, New York, United States
Local Institution - 020 — New York, New York, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
MUSC Rheumatology and Immunology Dept. — Charleston, South Carolina, United States
Greenville Hospital System — Greenville, South Carolina, United States
Sarah Cannon Research Institute Drug Development Unit — Nashville, Tennessee, United States
Texas Oncology, PA - Dallas 75246 — Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
Swedish Medical Center Cancer Institute Research — Seattle, Washington, United States
Yakima Valley Memorial Hospital/ North Star Lodge — Yakima, Washington, United States
Local Institution - 401 — Brussels, Belgium
Local Institution - 400 — Leuven, Belgium
Local Institution - 202 — Caen, France
Local Institution - 201 — Marseille Le Cedex, France
Local Institution - 205 — Pierre-Bénite, France
Local Institution - 203 — Toulouse, France
Local Institution - 200 — Villejuif, France
Local Institution - 303 — Bologna, Italy

Full record on ClinicalTrials.gov

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