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

NCT ID: NCT01177397

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-20
• Study Completion Date: 2016-12-09

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CC-223

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.

Group Type: EXPERIMENTAL

CC-223

Intervention Type: DRUG

Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Interventions

CC-223

Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA Neuro-Oncology Program

Los Angeles, California, United States

University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mayo Clinic Cancer Clinical Studies Unit

Rochester, Minnesota, United States

Billings Clinic

Billings, Montana, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Cancer Institute - Bellevue Hospital

New York, New York, United States

Sarah Cannon Research Institute Drug Development Unit

Nashville, Tennessee, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

Institut Claudius Regaud

Toulouse, , France

Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie

Villejuif, , France

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Sarah Cannon Research Institute UK

London, , United Kingdom

UCL Cancer Institute

London, , United Kingdom

Countries

United States; France; Spain; United Kingdom

Other Identifiers

CC-223-ST-001

Identifier Type: -

Identifier Source: org_study_id