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

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: NCT01353625
Recruitment Status : Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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 or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : April 25, 2011
Estimated Primary Completion Date : December 28, 2020
Estimated Study Completion Date : December 28, 2020


Arm Intervention/treatment
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.





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

Secondary Outcome Measures :
  1. 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).

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353625


Locations
Show Show 17 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Kristen Hege, MD Celgene Corporation
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01353625    
Other Study ID Numbers: CC-115-ST-001
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
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:
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Prostatic Neoplasms
Neoplasms
Neoplasm Metastasis
Glioblastoma
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Osteosarcoma
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Leukemia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Carcinoma, Squamous Cell
Neoplastic Processes
Pathologic Processes
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue