Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
Conditions
Solid Tumors - Non-Hodgkin's Lymphoma - Multiple Myeloma - Glioblastoma Multiforme - Oligodendroglioma - Hepatocellular Carcinoma - Diffuse Large B-cell Lymphoma - Mantle Cell Lymphoma
Conditions: official terms
Carcinoma, Hepatocellular - Glioblastoma - Lymphoma - Lymphoma, B-Cell - Lymphoma, Large B-Cell, Diffuse - Lymphoma, Mantle-Cell - Lymphoma, Non-Hodgkin - Multiple Myeloma - Neoplasms, Plasma Cell - Oligodendroglioma
Conditions: Keywords
Neoplasm, Malignancy, Carcinoma, Lymphoma, Multiple Myeloma, Pleiotropic Pathway Modifier, DNA-PK inhibitor, Advanced Solid Tumors, Glioblastoma multiforme, Hepatocellular Carcinoma, Diffuse large B-cell lymphoma, Mantel Cell Lymphoma, Advanced unresectable Solid Tumors
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CC-122 Type: Drug
Name: CC-122 Type: Drug
Name: CC-122 Type: Drug
Overall Status
Recruiting
Summary
The main purpose of this first human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.
Detailed Description
Initially, patients will be treated with oral CC-122 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-122. Different dose levels of CC-122 will be tested in a dose-rising study design.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Adults with histologically or cytologically-confirmed Non-Hodgkin Lymphoma, Multiple Myeloma or advanced solid tumors (limited to the tumor types below) who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no standard anticancer therapy exists.

2. DLBCL (Diffuse large B-cell lymphoma) subjects must have relapsed within 12 months of the start of the last cytotoxic chemotherapy including primary refractory disease.

3. Adequate organ function

4. Must have disease that is objectively measurable.

5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (except 0-1 in Hepatocellular Carcinoma and Diffuse Large B-cell Lymphoma)

6. Archival tumor samples and screening and on treatment biopsies. (archival not required in Multiple Myeloma. Screening and on treatment biopsies are not required in brain tumors and DLBCL patients during dose escalation of intermittent schedules

7. No prior Avastin Therapy for GBM patients.

8. Specific tumor types:

- Non-Hodgkin lymphoma:

- Diffuse large B-cell lymphoma

- Primary Brain Tumors: Primary glioblastoma multiforme or gliosarcoma,

- Hepatocellular Carcinoma

- Multiple Myeloma

Exclusion Criteria:

1. Symptomatic central nervous system metastases (excluding GBM). Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed.

2. Known symptomatic acute or chronic pancreatitis.

3. Any peripheral neuropathy ≥ NCI CTCAE grade 2.

4. Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management.

5. Impaired cardiac function or clinically significant cardiac diseases

6. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.

7. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy.

8. Major surgery ≤ 2 weeks prior to starting study drug or still recovering from post operative side effects.

9. Women who are pregnant or breast feeding. Adults of reproductive potential not employing two forms of birth control.

10. Known HIV infection.

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

12. Status post solid organ transplant.

13. Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogenic HSCT or either transplant type, if otherwise not fully recovered from HSCT related toxicity.

14. Most concurrent second malignancies
Locations
The Regents of the University of California
San Francisco, California, United States
Status: Recruiting
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
Status: Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Status: Recruiting
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Status: Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Greenville Hospital System
Nashville, Tennessee, United States
Status: Recruiting
Sarah Cannon Research Institute Tennessee Oncology Drug Development Unit
Nashville, Tennessee, United States
Status: Recruiting
Contact: SRCI Referral Line - 615-339-4214
Texas Oncology
Dallas, Texas, United States
Status: Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Status: Recruiting
Contact: Isabel Jimenez, RN, MSN - 210-593-5265 - Isabel.jimenez@start.stoh.com
North Star Lodge Cancer Center
Yakima, Washington, United States
Status: Recruiting
CHU Clemenceau
Clichy, Paris, France
Status: Withdrawn
Institut Gustave Roussy
Villejuif, Paris, France
Status: Recruiting
IPC
Marseille, France
Status: Recruiting
Insitut Universitaire du Cancer IUCT - Oncopole
Toulouse Cedrex, France
Status: Recruiting
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fo
Napoli, Campania, Italy
Status: Recruiting
Istituto di Ematologia e Oncologia Medica - L.A. Seragnoli A.O. Policlinico S.Orsola Malpighi
Bologna, Italy
Status: Recruiting
Instituto Nazionale Tumori-via Venezian
Milan, Italy
Status: Recruiting
Instituto clinic Humanitas
Rozzano, Italy
Status: Recruiting
Hospital del Mar
Barcelona, Spain
Status: Recruiting
Hospital Universitari Germans Trias i Pujol ICO
Barcelona, Spain
Status: Recruiting
Hospital Universitari Vall Hebrón
Barcelona, Spain
Status: Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Status: Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Status: Recruiting
Clinica Universidad de Navarra
Pamplona, Spain
Status: Recruiting
Hospital Universitario Clinco de Valencia
Valencia, Spain
Status: Recruiting
Start Date
August 2011
Completion Date
September 2016
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page