In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryCC-115-ST-001
NCT01353625

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

Kristen Hege, MDStudy Director

Wayne R. HullPh: 1-908-673-9727
  Email: whull@celgene.com

Trial Sites

U.S.A.
California
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Regina Deck Ph: 310-967-4397
  Email: Regina.Deck@cshs.org
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Paula Fiermonte, RN Ph: 415-885-7605
Florida
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Angela Akar Ph: 214-658-1964
  Email: Angela.Akar@Moffitt.org
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Dana Rathkopf, MD Ph: 646-422-4379
  Email: rathkopd@MSKCC.ORG
Tennessee
  Nashville
 Sarah Cannon Research Institute
 Vicky D Weikal Ph: 615-524-4052
  Email: Vicky.Weikal@scresearch.net
Texas
  Dallas
 Mary Crowley Medical Research Center at Sammons Cancer Center
 Meghan Degele Ph: 972-566-3062
  Email: mdegele@marycrowley.org
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Sandy Molina Ph: 713-792-8370
  Email: smolina@mdanderson.org
France
  Villejuif
 Institut Gustave Roussy
 Christophe Massard, MD Ph: +33142115210
  Email: christophe.massard@igr.fr
Germany
  Koeln
 Uniklinik Koln
 Barbara Eichhorst Ph: 49 221478
  Wuerzburg
 Universitatsklinikum Wuerzburg
Spain
  Barcelona
 Hospital Universitario Vall Hebrón
 Josep Tabernero, MD Ph: 34 93 489 4301
  Email: jtabernero@vhio.net
  Madrid
 Centro Integral Oncologico Clara Campal
 Manuel Hidalgo Ph: 34 91 756 78 25
  Email: mhidalgo@cnio.es
  San Sebastian
 Hospital de Donosti
 Enrique Bengoechea Ph: 003494300700 Ext.3232
  Email: enrique.bengoecheanerecan@osakidetza.net
  Sevilla
 Hospital Universidad Virgen Del Rocio
 Luis Paz-Ares, MD Ph: 34 955014134
  Email: luis.pazares.sspa@juntadeandalucia.es

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01353625
ClinicalTrials.gov processed this data on October 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top