Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advance… (NCT01421524) | Clinical Trial Compass
CompletedPhase 1
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
United States271 participantsStarted 2011-09-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Tumor specific inclusion criteria:
✓. At least 4 weeks from last dose of therapeutic glucocorticosteroids. Adrenal replacement doses of glucocorticosteroids (up to the equivalent of 10 mg daily prednisone) are allowed.
✓. Biopsies (DLBLC, MM): Diagnostic archival FFPE (either in tumor blocks or sectioned/mounted specimens) may be submitted in lieu of a pre-study research biopsy if it has been obtained no more than 1 year prior to enrollment and only after discussion with the Celgene Medical Monitor
✓. If not specified above as tumor specific parameter subjects must have the following laboratory and hematologic parameters as follows:
Exclusion criteria
✕. 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.