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Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01177397
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 9, 2010
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE July 20, 2010
Actual Primary Completion Date November 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • Safety [ Time Frame: From the time of informed consent, throughout dosing period and for 21 days after the last dose of CC-223 ]
    To determine the safety profile and dose-limiting toxicity of CC-223 using NCI CTCAE v4.
  • Pharmacokinetics [ Time Frame: Throughout the first cycle (30 days) through to the first day of Cycle 2. ]
    Standard variables (eg. Cmax, AUC, half-life) to define the PK profile for single and multiple doses of oral CC-223.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
  • Pharmacodynamics [ Time Frame: Throughout the first cycle (30 days) through to the first day of Cycle 2. ]
    Phosphorylation inhibition changes by levels of S6, 4EBP (for mTORC1) and AKT (for mTORC2) in circulating granulocytes, and tumor tissue (when available).
  • Efficacy [ Time Frame: Every 2-3 months until proof of tumor progression ]
    Tumor response rates using appropriate objective criteria for various malignancies
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • Pharmacodynamics [ Time Frame: Throughout the first cycle (30 days) through to the first day of Cycle 2. ]
    Phosphorylation inhibition changes by levels of S6, 4EBP (for mTORC1) and AKT (for mTORC2) in circulating granulocytes, and tumor tissue (when available).
  • Efficacy [ Time Frame: Every two months until proof of tumor progression ]
    Tumor response rates and duration using objective criteria appropriate for type of tumor evaluated (eg. RECIST)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Official Title  ICMJE 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
Brief Summary The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: CC-223
Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.
Study Arms  ICMJE Experimental: CC-223
All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.
Intervention: Drug: CC-223
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
173
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2010)
100
Actual Study Completion Date  ICMJE December 9, 2016
Actual Primary Completion Date November 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01177397
Other Study ID Numbers  ICMJE CC-223-ST-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kristen Hege, M.D. Celgene
PRS Account Celgene
Verification Date November 2017

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