Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01353625 : Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01353625      |      Link to official Clinicaltrials.gov listing
Locations
Villejuif,
France

Facility: Department of Medical Oncology-Institut Gustave Roussy
Investigator:
Contact: Christophe Massard, MD Phone: +33142115210
Click HERE to send email to this center

Koeln,
Germany

Facility: Uniklinik Koln
Investigator:
Contact: Barbara Eichhorst Phone: 49 221478
Email not avaialable

Wuerzburg,
Germany

Facility: Universitatsklinikum Wuerzburg
Investigator:
Contact:
Email not avaialable

Barcelona,
Spain

Facility: Hospital Universitario Vall Hebrón
Investigator:
Contact: Josep Tabernero, MD Phone: 34 93 489 4301
Click HERE to send email to this center

Madrid,
Spain

Facility: Unidad de Fase I 3º planta Hospital Universitario Madrid Sanchinarro
Investigator:
Contact: Manuel Hidalgo Phone: 34 91 756 78 25
Click HERE to send email to this center

San Sebastian,
Spain

Facility: Hospital de Donosti
Investigator:
Contact: Enrique Bengoechea Phone: 003494300700
Click HERE to send email to this center

Sevilla,
Spain

Facility: Pasillo Onco-Hematología. Sala de Protocolos Hospital Universitario Virgen del Rocío
Investigator:
Contact: Luis Paz-Ares, MD Phone: 34 955014134
Click HERE to send email to this center

Los Angeles, California
Facility: Cedars-Sinai Medical Center
Investigator:
Contact: Regina Deck Phone: 310-967-4397
Click HERE to send email to this center

San Francisco, California
Facility: University of California at San Francisco
Investigator:
Contact: Paula Fiermonte, RN Phone: 415-885-7605
Email not avaialable

Tampa, Florida
Facility: Moffitt Cancer Center & Research Institute
Investigator:
Contact: Angela Akar Phone: 214-658-1964
Click HERE to send email to this center

New York, New York
Facility: Memorial Sloan-Kettering Cancer Center
Investigator:
Contact: Dana Rathkopf, MD Phone: 646-422-4379
Click HERE to send email to this center

Nashville, Tennessee
Facility: Sarah Cannon Research Institute (SCRI) Drug Development Unit
Investigator:
Contact: Vicky D Weikal Phone: 615-524-4052
Click HERE to send email to this center

Dallas, Texas
Facility: Mary Crowley Cancer Research Centers
Investigator:
Contact: Meghan Degele Phone: 972-566-3062
Click HERE to send email to this center

Houston, Texas
Facility: The University of Texas, MD Anderson Cancer Center
Investigator:
Contact: Sandy Molina Phone: 713-792-8370
Click HERE to send email to this center




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