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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

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

Details

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.

Keywords

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 Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma,

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, USA
  • UCLA Neuro-Oncology Program
    Los Angeles, California, 90095, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01177397
Phase
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
January 2017