Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01421524
First received: August 19, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Non-Hodgkin's Lymphoma
Multiple Myeloma
Glioblastoma Multiforme
Oligodendroglioma
Hepatocellular Carcinoma
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Drug: CC-122 HCL
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Multi Center, Open-Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Dose-Limiting Toxicity [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Dose-limiting toxicities (DLTs) - Grade II or higher toxicity suspected to be drug related

  • Non Tolerated Dose [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Non Tolerated Dose (NTD)- when two or more out of six evaluable subjects in a cohort experience drug related dose limiting toxicities during Cycle 1.

  • Maximum Tolerated Dose [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Maximum Tolerated Dose - the last dose level below the non-tolerated dose with zero or one out of six evaluable subjects experiencing a dose limiting toxicity during cycle 1.

  • Maximum Observed Concentration [ Time Frame: Up to Day 16 ] [ Designated as safety issue: No ]
    Maximum observed concentration in plasma for C-122.

  • Time to concentration [ Time Frame: Up to Day 16 ] [ Designated as safety issue: No ]
    Time to concentration for C-122

  • Terminal half-life [ Time Frame: Up to Day 16 ] [ Designated as safety issue: No ]
    Terminal half-life for C-122

  • Apparent Total Body Clearance [ Time Frame: Up to Day 16 ] [ Designated as safety issue: No ]
    Apparent total body clearance for CC-122

  • Apparent Volume Distribution [ Time Frame: Up to Day 16 ] [ Designated as safety issue: No ]
    Apparent volume distribution of C-122

  • Creatinine Clearance [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
    Creatinine clearance

  • CC-122 in urine [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
    The amount of CC-122 excreted in the urine


Secondary Outcome Measures:
  • Response Rate [ Time Frame: Up to 1 Year ] [ Designated as safety issue: No ]
    The response rate of each tumor types based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), International Workshop Criteria (IWC) for NHL, International Uniform Response Criteria for Multiple Myeloma (IURC), or Responses Assessment for Neuro-Oncology (RANO) working group for Glioblastama multiforme (GBM)

  • Determine CNS penetration of CC-122 following the administration of CC-122 [ Time Frame: C1 Days 8, 15, and 22 ] [ Designated as safety issue: No ]
    Tissue concentration of CC-122 in salvage resection specimens from subjects with GBM or in CSF specimens from subjects undergoing lumbar puncture


Estimated Enrollment: 140
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-122 HCL
5 mg or higher dose of CC-122 (depending on the cohort) administered orally for 28 days in 28 day cycles until disease progression, unacceptable toxicity, or subject/physician decision to withdraw
Drug: CC-122 HCL
0.5 mg or higher dose of CC-122 (depending on the cohort) administered orally for 28 days in 28 day cycles until disease progression, unacceptable toxicity, or subject/physician decision to withdraw.
Other Name: CC-122 HCL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults 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. Adequate organ function
  3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (except 0-1 in Hepatocellular Carcinoma) 4 . Archival tumor samples and screening biopsy (archival not required in Multiple Myeloma and screening not required in brain tumors)

5. Specific tumor types:

  • Non-Hodgkin lymphoma:
  • Diffuse large B-cell lymphoma and Mantle Cell Lymphoma
  • Primary Brain Tumors:
  • Primary glioblastoma multiforme or gliosarcoma, WHO Grade II oligodendrogliomas, grade III anaplastic oligodendrogliomas and grade III anaplastic astrocytomas.
  • 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.

6. Impaired cardiac function or clinically significant cardiac diseases 7. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.

8. 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.

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

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

11. Known HIV infection. 12. Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC.

13. Status post solid organ transplant. 14. 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.

15. Most concurrent second malignancies

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421524

Contacts
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, California
The Regents of the University of California Recruiting
San Francisco, California, United States, 94143
United States, Michigan
The Regents of the University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute Tennessee Oncology Drug Development Unit Recruiting
Nashville, Tennessee, United States, 37205
Contact: SRCI Referral Line    615-339-4214      
Greenville Hospital System Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Oncology Recruiting
Dallas, Texas, United States, 75246
South Texas Accelerated Research Therapeutics, LLC (START) Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5265    Isabel.jimenez@start.stoh.com   
Contact: Rebecca R Arcos, MS    210-593-5284    Rebecca.arcos@start.stoh.com   
Principal Investigator: Drew Rasco, M.D.         
United States, Washington
North Star Lodge Cancer Center Recruiting
Yakima, Washington, United States, 98902
France
CHU Clemenceau Recruiting
Clichy, Paris, France, 92110
Institut Gustave Roussy Recruiting
Villejuif, Paris, France, 94805
IPC Recruiting
Marseille, France, 13009
Italy
Instituto Nazionale Tumori-via Venezian Recruiting
Milan, Italy, 20133
Instituto clinic Humanitas Recruiting
Rozzano, Italy, 20089
Spain
Hospital Universitari Vall Hebrón Recruiting
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario Clinco de Valencia Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Jorge DiMartino, M.D., Ph.D Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01421524     History of Changes
Other Study ID Numbers: CC-122-ST-001
Study First Received: August 19, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Celgene Corporation:
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

Additional relevant MeSH terms:
Carcinoma
Glioblastoma
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Oligodendroglioma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms
Lymphoma, Mantle-Cell
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014