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

Celgene

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hormone Receptor-Positive Breast Cancer; Glioblastoma Multiforme; Multiple Myeloma; Hepatocellular Carcinoma; Diffuse Large B-Cell Lymphoma; Neuroendocrine Tumors of Non-Pancreatic Origin; Non-Small Cell Lung Cancer

Treatments: Drug: CC-223

Study type: Interventional

Funder types: Industry

Identifiers

NCT01177397

CC-223-ST-001

Details and patient eligibility

About

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.

Full description

Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 1 patient group

CC-223

Experimental group

Description:

All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.

Treatment:

Drug: CC-223