This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).
This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose. The starting dose is CC-292 375 mg twice daily and Lenalidomide 10 mg once daily. After review of the data for dose limiting toxicities (DLTs), the second dose level will be enrolled. Doses for this second cohort are CC-292 500 mg twice daily and lenalidomide 10 mg once daily. Additional doses of lenalidomide in combination with CC-292 may be evaluated to accurately determine the maximum tolerated dose. Once the maximum tolerated dose and/or optimal biologic effect has been ascertained, an expansion cohort of 24 subjects may be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CC-292-will be given twice daily on Days 8-28 of Cycle 1 and on Days 1-28 of the remaining 28-day cycles.
Lenalidomde will be given once daily on Days 1-28 of 28-day cycles.
Clearview Cancer Institute Oncology Specialties, P.C
Huntsville, Alabama, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Adverse Events
Number of participants with adverse events
Time frame: Up to 5 years
Percentage of Participants Who Have Received Some Form of Response
Response rate is defined as the percentage of participants who have achieved some form of response including: a Complete Response (CR), a CR with incomplete bone marrow recovery, a Nodular Partial Response (PR), a Nodal PR or a PR with lymphoctyosis) based on the International Workshop for Chronic Lymphocytic Leukemia and lymphoma guidelines (IWCLL).
Time frame: Up to 2 years
PK-Cmax
Maximum observed plasma concentration
Time frame: Up to 15 days
PK-Tmax
Time to maximum observed plasma concentration
Time frame: Up to 15 days
PK-λz
Terminal phase rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration
Time frame: Up to 15 days
PK-t1/2
Estimate of the terminal elimination half-life in plasma
Time frame: Up to 15 days
PK-AUC (0-t)
Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point
Time frame: Up to 15 days
PK-AUC0-∞
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Mount Sinai School of Medicine
New York, New York, United States
The West Clinic
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Universitatsklinik fur Innere Medizin
Innsbruck, Austria
AKh Linz
Linz, Austria
Universitatsklinik der PMU
Salzburg, Austria
Allgemeines Krankenhaus Wien
Vienna, Austria
...and 1 more locations
Area under the plasma concentration time curve from time zero extrapolated to infinity.
Time frame: Up to 15 days