This trial is active, not recruiting.

Conditions multiple myeloma, diffuse large b-cell lymphoma, glioblastoma multiforme, hepatocellular carcinoma, non-small cell lung cancer, neuroendocrine tumors of non-pancreatic origin, hormone receptor-positive breast cancer
Treatment cc-223
Phase phase 1/phase 2
Target mTOR
Sponsor Celgene Corporation
Start date July 2010
End date December 2016
Trial size 173 participants
Trial identifier NCT01177397, CC-223-ST-001


The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.
Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Primary Outcomes

time frame: From the time of informed consent, throughout dosing period and for 21 days after the last dose of CC-223
time frame: Throughout the first cycle (30 days) through to the first day of Cycle 2.

Secondary Outcomes

time frame: Throughout the first cycle (30 days) through to the first day of Cycle 2.
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, Non-Hodgkin Lymphoma or multiple myeloma - Patients have not tolerated or progressed on standard therapy, and no further standard therapy is available - Archival and screening tumor biopsy - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy) - Adequate organ function Exclusion Criteria: - Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug - Symptomatic brain metastases (prior Rx and stable metastases are OK) - Acute or chronic liver or renal disease or pancreatitis - Diarrhea ≥ Grade 2, impaired GI absorption - Impaired cardiac function - Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5% - Peripheral neuropathy ≥ Grade 2 - Pulmonary fibrosis - Known HIV infection - Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC - Pregnant, inadequate contraception - Most concurrent second malignancies

Additional Information

Official title A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma
Description Initially, patients will be treated with oral CC-223 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-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.