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.
A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.
This trial is enrolling additional Multiple Myeloma (MM) subjects in a separate cohort defined as MM-2 to evaluate tolerability, safety and preliminary efficacy of CC-122 formulated capsule alone or in combination with DEX on intermittent dosing schedule (5 of 7 days of the week) in Pomalidomide-naïve subjects. Preliminary efficacy data in Multiple Myeloma subjects, warrants further exploration of CC-122 in MM on intermittent schedules to assess if dose intensity and tolerability can be improved. Initially, patients will be treated with oral CC-122 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-122. Different dose levels of CC-122 will be tested in a dose-rising study design.
Multiple Myeloma Lymphoma, Large B-Cell, Diffuse Pleiotropic Pathway Modifier Glioblastoma Lymphoma Primary Central Nervous System Lymphoma (PCNSL) Neoplasm Malignancy Carcinoma DNA-PK inhibitor Advanced Solid Tumors Glioblastoma multiforme Hepatocellular Carcinoma Diffuse large B-cell lymphoma Mantel Cell Lymphoma Advanced unresectable Solid Tumors Primary CNS Lymphoma Polystyrene sulfonic acid
Open to people ages 18 years and up
Measurable disease criteria:
Tumor specific inclusion criteria:
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.
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