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A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

To determine the safety profile and dose-limiting toxicity of CC-223 using NCI CTCAE v4.

Outcome Time Frame:

From the time of informed consent, throughout dosing period and for 21 days after the last dose of CC-223

Safety Issue:

Yes

Principal Investigator

Kristen Hege, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CC-223-ST-001

NCT ID:

NCT01177397

Start Date:

July 2010

Completion Date:

February 2016

Related Keywords:

  • 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
  • Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma,
  • Multiple Myeloma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Glioblastoma
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Neuroendocrine Tumors
  • Carcinoma, Hepatocellular

Name

Location

Mayo ClinicRochester, Minnesota  55905
NYU Cancer InstituteNew York, New York  10016
University of California at San FranciscoSan Francisco, California  94115
Billings ClinicBillings, Montana  59107-7000
Moffitt Cancer Center & Research InstituteTampa, Florida  33612-9497
Mary Crowley Cancer Research CentersDallas, Texas  75201
Sarah Cannon Research Institute (SCRI)Nashville, Tennessee  37203
UCLA Neuro-Oncology ProgramLos Angeles, California  90095-1769
Cedars-Sinai Medical Center-Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California  90048
John Theurer Cancer Center at Hackensack UniversityHackensack, New Jersey  07601