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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
N/A
Not Enrolling
Both
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
toxicities

- 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
therapy

- 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:

Interventional

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:

No

Principal Investigator

Chandra Belani, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CYC202-06-14 (A1)

NCT ID:

NCT00372073

Start Date:

July 2006

Completion Date:

March 2012

Related Keywords:

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Rush University Medical CenterChicago, Illinois  60612-3824
Southwest Regional Cancer CenterAustin, Texas  78705
Nevada Cancer Research FoundationLas Vegas, Nevada  89109
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Center for Oncology Research and TreatmentDallas, Texas  75230
New Mexico Oncology Hematology ConsultantsAlbuquerque, New Mexico  87102
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Columbia Presbyterian Medical CenterNew York, New York  10032
The University of ChicagoChicago, Illinois  60637
The Family Cancer CenterCollierville, Tennessee  38017
VA Sierra Nevada Health Care SystemReno, Nevada  89502
Pasco Hernando OncologyNew Port Richey, Florida  34652
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Nebraska Medical CenterOmaha, Nebraska  68198
Pacific Coast Hematology Oncology GroupFountain Valley, California  92708
University of Maryland, Greenebaun Cancer CenterBaltimore, Maryland  21201
University of Pittsburg Cancer InstitutePittsburgh, Pennsylvania  15232
East Texas Medical CenterTyler, Texas  75701
Danville Hematology OncologyDanville, Virginia  24541