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

Celgene

Status and phase: Completed; Phase 1

Conditions: Glioblastoma Multiforme; Ewing's Osteosarcoma; Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis; Chronic Lymphocytic Leukemia; Prostate Cancer

Treatments: Drug: CC-115

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353625

CC-115-ST-001

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

CC-115

Experimental group

Treatment:

Drug: CC-115