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

August 19, 2011
April 2, 2014
August 2011
March 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01421524 on ClinicalTrials.gov Archive Site
  • 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
Response Rate [ Time Frame: Up to 1 Year ] [ Designated as safety issue: No ]
The response rate of each tumor type 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).
Not Provided
Not Provided
 
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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
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
Intervention: Drug: CC-122 HCL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2015
March 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
United States,   France,   Italy,   Spain
 
NCT01421524
CC-122-ST-001
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Jorge DiMartino, M.D., Ph.D Celgene Corporation
Celgene Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP