This trial is active, not recruiting.

Conditions glioblastoma multiforme, squamous cell carcinoma of head and neck, prostate cancer, ewing's osteosarcoma, chronic lymphocytic leukemia, neoplasm metastasis
Treatment cc-115
Phase phase 1
Sponsor Celgene Corporation
Start date April 2011
End date September 2018
Trial size 119 participants
Trial identifier NCT01353625, CC-115-ST-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

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

Secondary Outcomes

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
time frame: Every 2-3 months until proof of tumor progression

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma - Progressed or not tolerated standard therapy, and no further standard therapy is available - Archival and screening tumor biopsy - Eastern Cooperative Oncology Group Performance Status: 0 or 1 - Adequate organ function Exclusion Criteria: - Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter - Symptomatic brain metastases (prior treatment and stable metastases are allowed) - Acute or chronic renal disease or pancreatitis - Diarrhea ≥ Grade 2, impaired gastrointestinal absorption - Impaired cardiac function - History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ≥6.5% - Peripheral neuropathy ≥ Grade 2 - Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C (unless associated with hepatocellular cancer) - Pregnant, inadequate contraception, breast feeding - Most concurrent second malignancies - Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.