Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.
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|ClinicalTrials.gov Identifier: NCT01353625|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Squamous Cell Carcinoma of Head and Neck Prostate Cancer Ewing's Osteosarcoma Chronic Lymphocytic Leukemia Neoplasm Metastasis||Drug: CC-115||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies|
|Actual Study Start Date :||April 25, 2011|
|Estimated Primary Completion Date :||December 28, 2020|
|Estimated Study Completion Date :||December 28, 2020|
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 [ 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 ]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).
- Anti-Tumor Efficacy [ Time Frame: Every 2-3 months until proof of tumor progression ]Tumor response rates using appropriate objective criteria for various malignancies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353625
|Study Director:||Kristen Hege, MD||Celgene Corporation|