Clinical Trial Details
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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
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

- 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.
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