Prostate Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT01353625

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 17 Locations for this study

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Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
UCLA
Los Angeles California, 90095, United States
University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute
San Francisco California, 94115, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Sarah Cannon Research Institute Drug Development Unit
Nashville Tennessee, 37203, United States
Mary Crowley Medical Research Center
Dallas Texas, 75201, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77303, United States
Gustave Roussy
Villejuif Cedex , 94805, France
Uniklinik Koln
Koeln , 50937, Germany
Universitatsklinikum Wurzburg
Würzburg , 97070, Germany
Hospital Val d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Madrid Sanchinarro
Madrid , 28050, Spain
Hospital de Donosti
San Sebastián (Guipuzcoa) , 20014, Spain
Hospital Virgen del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT01353625

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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