Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
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.
Clareo Health | Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.
