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.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 17 Locations for this study
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Tampa Florida, 33612, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
New York New York, 10021, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75201, United States
Houston Texas, 77303, United States
Villejuif Cedex , 94805, France
Koeln , 50937, Germany
Würzburg , 97070, Germany
Barcelona , 08035, Spain
Madrid , 28050, Spain
San Sebastián (Guipuzcoa) , 20014, Spain
Sevilla , 41013, Spain
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.