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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01353625
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries France, Germany, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme, Squamous Cell Carcinoma of Head and Neck, Prostate Cancer, Ewing's Osteosarcoma, Chronic Lymphocytic Leukemia, Neoplasm Metastasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: CC-115

Interventions

Drug: - CC-115

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

UCLA, Los Angeles, California

Status

Address

UCLA

Los Angeles, California, 90095

San Francisco, California

Status

Address

University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute

San Francisco, California, 94115

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Detroit, Michigan

Status

Address

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

Nashville, Tennessee

Status

Address

Sarah Cannon Research Institute Drug Development Unit

Nashville, Tennessee, 37203

Mary Crowley Medical Research Center, Dallas, Texas

Status

Address

Mary Crowley Medical Research Center

Dallas, Texas, 75201

Houston, Texas

Status

Address

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77303

International Sites

Gustave Roussy, Villejuif Cedex, France

Status

Address

Gustave Roussy

Villejuif Cedex, , 94805

Uniklinik Koln, Koeln, Germany

Status

Address

Uniklinik Koln

Koeln, , 50937

Universitatsklinikum Wurzburg, Würzburg, Germany

Status

Address

Universitatsklinikum Wurzburg

Würzburg, , 97070

Hospital Val d'Hebron, Barcelona, Spain

Status

Address

Hospital Val d'Hebron

Barcelona, , 08035

Madrid, Spain

Status

Address

Hospital Universitario Madrid Sanchinarro

Madrid, , 28050

Hospital de Donosti, San Sebastián (Guipuzcoa), Spain

Status

Address

Hospital de Donosti

San Sebastián (Guipuzcoa), , 20014

Hospital Virgen del Rocio, Sevilla, Spain

Status

Address

Hospital Virgen del Rocio

Sevilla, , 41013

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