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Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT01353625
First received: May 12, 2011
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

Condition Intervention Phase
Glioblastoma Multiforme Squamous Cell Carcinoma of Head and Neck Prostate Cancer Ewing's Osteosarcoma Chronic Lymphocytic Leukemia Neoplasm Metastasis Drug: CC-115 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Dose-Limiting Toxicity [ Time Frame: Continuously for 28 days after starting treatment ]
  • Non-Tolerated Dose [ Time Frame: Continuously for 28 days after starting treatment ]
  • Maximum Tolerated Dose [ Time Frame: Continuously for 28 days after starting treatment ]
  • Maximum Observed Concentration in Plasma of CC-115 [ Time Frame: Days 1, 2, 15, 16 of treatment ]
  • Area Under the Concentration-Time Curve for CC-115 [ Time Frame: Days 1, 2, 15 and 16 of treatment ]
  • Time to Maximum Concentration of CC-115 [ Time Frame: Days 1, 2, 15, and 16 of treatment ]
  • Terminal Half-Life for CC-115 [ Time Frame: Days 1, 2, 15, and 16 of treatment ]
  • Apparent Total Body Clearance of CC-115 [ Time Frame: Days 1, 2, 15 and 16 of treatment ]
  • Apparent Volume of Distribution of CC-115 [ Time Frame: Days 1, 2, 15, and 16 of treatment ]
  • Accumulation Index of CC-115 [ Time Frame: Days 1, 2, 15 and 16 of treatment ]

Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment ]
    Phosphorylation inhibition determined by changes in the levels of multiple biomarkers including S6 and, 4EBP (for mTORC1), AKT (for mTORC2) and other appropriate biomarkers in circulating granulocytes and tumor tissue (when available).

  • Anti-Tumor Efficacy [ Time Frame: Every 2-3 months until proof of tumor progression ]
    Tumor response rates using appropriate objective criteria for various malignancies


Enrollment: 119
Actual Study Start Date: April 25, 2011
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-115 Drug: CC-115

Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity).

Part B: Optimal dose schedule is administered in 28-day cycles until disease progression.


Detailed Description:
Latest amendment clarifies that Chronic Lymophocytic Leukemia (CLL) includes T-cell Prolymphocytic Leukemia (T-PLL). Prior treatment with some drugs targeting mTOR, P13K and related pathways is now permitted.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma
  • Progressed or not tolerated standard therapy, and no further standard therapy is available
  • Archival and screening tumor biopsy
  • Eastern Cooperative Oncology Group Performance Status: 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter
  • Symptomatic brain metastases (prior treatment and stable metastases are allowed)
  • Acute or chronic renal disease or pancreatitis
  • Diarrhea ≥ Grade 2, impaired gastrointestinal absorption
  • Impaired cardiac function
  • History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ≥6.5%
  • Peripheral neuropathy ≥ Grade 2
  • Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C (unless associated with hepatocellular cancer)
  • Pregnant, inadequate contraception, breast feeding
  • Most concurrent second malignancies
  • Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.
  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: NCT01353625

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA
Los Angeles, California, United States, 90095
University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute
San Francisco, California, United States, 94115
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Sarah Cannon Research Institute Drug Development Unit
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77303
France
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Germany
Uniklinik Koln
Koeln, Germany, 50937
Universitatsklinikum Wurzburg
Würzburg, Germany, 97070
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050
Hospital de Donosti
San Sebastián (Guipuzcoa), Spain, 20014
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Celgene
Investigators
Study Director: Kristen Hege, MD Celgene Corporation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01353625     History of Changes
Other Study ID Numbers: CC-115-ST-001
Study First Received: May 12, 2011
Last Updated: May 31, 2017

Keywords provided by Celgene:
Neoplasm
Malignancy
Carcinoma
Lymphoma
Leukemia
Multiple myeloma
mTOR kinase inhibitor
Castration-resistant prostate cancer
Hormone-resistant prostate cancer
Diffuse Large B-cell lymphoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Squamous Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Glioblastoma
Osteosarcoma
Neoplasm Metastasis
Head and Neck Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Leukemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 21, 2017