Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 13, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Celgene
- Interventions being studied
- Drug: CC-223
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterLos Angeles, California
- UCLA Neuro-Oncology ProgramLos Angeles, California
- University of California, San Francisco Hellen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Moffitt Cancer CenterTampa, Florida
- Mayo Clinic Cancer Clinical Studies UnitRochester, Minnesota
- Billings ClinicBillings, Montana
- Hackensack University Medical CenterHackensack, New Jersey
- NYU Cancer Institute - Bellevue HospitalNew York, New York
- Sarah Cannon Research Institute Drug Development UnitNashville, Tennessee
- Mary Crowley Medical Research CenterDallas, Texas
- Institut Claudius RegaudToulouse
- Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologieVillejuif
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2022. Always confirm current availability with the study team.