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

Overview

This is a clinical trial for men and women with relapsed or refractory multiple myeloma. The main purpose of this study is to test the safety of a new experimental oral drug called CC-122, a Pleiotropic Pathway Modulator (PPM). This class of medication aims to stop the growth of cancerous cells by binding to a protein complex linked to cell division.

SparkCures ID 209
Trial Phase Phase 1
Enrollment 140 Patients
Treatments
  • CC-122
Trial Sponsors
  • Celgene Corporation
NCT Identifier

NCT01421524

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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:
    1. Non-Hodgkin lymphoma:
    2. Diffuse large B-cell lymphoma and Mantle Cell Lymphoma
    3. Primary Brain Tumors:
    4. Primary glioblastoma multiforme or gliosarcoma, WHO Grade II oligodendrogliomas, grade III anaplastic oligodendrogliomas and grade III anaplastic astrocytomas.
    5. Hepatocellular Carcinoma
    6. 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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