A Phase 1 interventional study of CC-115 in Glioblastoma Multiforme, Squamous Cell Carcinoma of Head and Neck and Prostate Cancer, sponsored by Celgene. Completed at 17 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Celgene · Phase 1, Interventional, and Treatment
The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.
Latest amendment clarifies that Chronic Lymophocytic Leukemia (CLL) includes T-cell Prolymphocytic Leukemia (T-PLL). Prior treatment with some drugs targeting mTOR, P13K and related pathways is now permitted.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 118 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CC-115
Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: Optimal dose schedule is administered in 28-day cycles until disease progression.
Dose-Limiting Toxicity
Time frame: Continuously for 28 days after starting treatment
Non-Tolerated Dose
Time frame: Continuously for 28 days after starting treatment
Maximum Tolerated Dose
Time frame: Continuously for 28 days after starting treatment
Maximum Observed Concentration in Plasma of CC-115
Time frame: Days 1, 2, 15, 16 of treatment
Area Under the Concentration-Time Curve for CC-115
Time frame: Days 1, 2, 15 and 16 of treatment
Time to Maximum Concentration of CC-115
Time frame: Days 1, 2, 15, and 16 of treatment
Terminal Half-Life for CC-115
Time frame: Days 1, 2, 15, and 16 of treatment
Apparent Total Body Clearance of CC-115
Time frame: Days 1, 2, 15 and 16 of treatment
Apparent Volume of Distribution of CC-115
Time frame: Days 1, 2, 15, and 16 of treatment
Accumulation Index of CC-115
Time frame: Days 1, 2, 15 and 16 of treatment
Pharmacodynamics
Phosphorylation inhibition determined by changes in the levels of multiple biomarkers including S6 and, 4EBP (for mTORC1), AKT (for mTORC2) and other appropriate biomarkers in circulating granulocytes and tumor tissue (when available).
Time frame: Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment
Anti-Tumor Efficacy
Tumor response rates using appropriate objective criteria for various malignancies
Time frame: Every 2-3 months until proof of tumor progression
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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