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A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

Inclusion Criteria:

- Adult patients with histologically-confirmed recurrent non-small cell lung cancer
have had at least two prior systemic treatment regimens

- Must have measurable disease according to RECIST

- Eastern Cooperative Oncology Group performance status 0-1

- Adequate bone marrow, hepatic and renal function

- Ability to swallow capsules

- At least 3 weeks from prior systemic treatments including investigational anti-cancer
therapy, at least 7 days from prior radiation therapy and have recovered from prior

- At least 3 weeks from major surgery

Exclusion Criteria:

- Non-small cell cancer histology contains a component of small cell lung cancer

- Previously untreated CNS metastasis or progressive CNS metastasis

- Prior treatment with a CDK inhibitor

- Currently receiving radiotherapy, biological therapy, or any other investigational

- Uncontrolled intercurrent illness

- Having other cancers that have been treated with chemotherapy or biological therapy
in the past 5 years with the exception of adequately treated in situ cervical cancer
or basal cell skin cancer

- Pregnant or lactating women

- Known to be HIV-positive

- Active hepatitis B and/or hepatitis C infection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

over the course of the study

Safety Issue:


Principal Investigator

Chandra Belani, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:

CYC202-06-14 (A1)



Start Date:

July 2006

Completion Date:

March 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Arizona Cancer Center Tucson, Arizona  85724
Rush University Medical Center Chicago, Illinois  60612-3824
Southwest Regional Cancer Center Austin, Texas  78705
Nevada Cancer Research Foundation Las Vegas, Nevada  89109
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Center for Oncology Research and Treatment Dallas, Texas  75230
New Mexico Oncology Hematology Consultants Albuquerque, New Mexico  87102
Dana Farber Cancer Institute Boston, Massachusetts  02115
Columbia Presbyterian Medical Center New York, New York  10032
The University of Chicago Chicago, Illinois  60637
The Family Cancer Center Collierville, Tennessee  38017
VA Sierra Nevada Health Care System Reno, Nevada  89502
Pasco Hernando Oncology New Port Richey, Florida  34652
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Nebraska Medical Center Omaha, Nebraska  68198
Pacific Coast Hematology Oncology Group Fountain Valley, California  92708
University of Maryland, Greenebaun Cancer Center Baltimore, Maryland  21201
University of Pittsburg Cancer Institute Pittsburgh, Pennsylvania  15232
East Texas Medical Center Tyler, Texas  75701
Danville Hematology Oncology Danville, Virginia  24541