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A Phase 1a/b, Multicenter, Open Label, Dose-Finding 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.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Non-Hodgkin Lymphoma, Glioblastoma Multiforme, Squamous Cell Carcinoma of Head and Neck, Prostate Cancer, Ewing's Osteosarcoma, Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Phase 1a/b, Multicenter, Open Label, Dose-Finding 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.


Minimum age limit is 18 years however subjects with Ewing's sarcoma may be 12 years or
older. Prostate cancer subjects have to be 'castration-' or 'hormone-' resistant.


Inclusion Criteria:



- Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small
lymphocytic lymphoma, 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose-Limiting Toxicity

Outcome Time Frame:

Continuously for 28 days after starting treatment

Safety Issue:

Yes

Principal Investigator

Kristen Hege, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Federal Government

Study ID:

CC-115-ST-001

NCT ID:

NCT01353625

Start Date:

April 2011

Completion Date:

April 2015

Related Keywords:

  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Glioblastoma Multiforme
  • Squamous Cell Carcinoma of Head and Neck
  • Prostate Cancer
  • Ewing's Osteosarcoma
  • Chronic Lymphocytic Leukemia
  • Neoplasm
  • Malignancy
  • Carcinoma
  • Lymphoma
  • Leukemia
  • Multiple myeloma
  • mTOR kinase inhibitor
  • Castration-resistant prostate cancer
  • Hormone-resistant prostate cancer
  • Diffuse Large B-cell lymphoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Glioblastoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Osteosarcoma
  • Prostatic Neoplasms
  • Hematologic Neoplasms
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Cedars-Sinai Medical Center Los Angeles, California  90048
Henry Ford Health System Detroit, Michigan  48202
University of California at San Francisco San Francisco, California  94115
The University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Moffitt Cancer Center & Research Institute Tampa, Florida  33612-9497
Karmanos Cancer Center Detroit, Michigan  48201
NYU Clinical Cancer Center New York, New York  10016
University of Michigan, Comprehensive Cancer Center Ann Arbor, Michigan  48109
Mary Crowley Cancer Research Centers Dallas, Texas  75201
UCLA Neuro-Oncology Program Los Angeles, California  90095-1769
Sarah Cannon Research Institute (SCRI) Drug Development Unit Nashville, Tennessee  37203