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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



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