Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma

• Status: Completed
• Trial end date: 2016-12-09
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

Inclusion Criteria:

• Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple myeloma

• Patients have not tolerated or progressed on standard therapy, and no further standard therapy is available

• Archival and screening tumor biopsy

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy)

• Adequate organ function

Exclusion Criteria:

• Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug

• Symptomatic brain metastases (prior Rx and stable metastases are OK)

• Acute or chronic liver or renal disease or pancreatitis

• Diarrhea ≥ Grade 2, impaired GI absorption

• Impaired cardiac function

• Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5%

• Peripheral neuropathy ≥ Grade 2

• Pulmonary fibrosis

• Known HIV infection

• Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC

• Pregnant, inadequate contraception

• Most concurrent second malignancies