Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00372073
First received: September 3, 2006
Last updated: November 7, 2011
Last verified: November 2011

September 3, 2006
November 7, 2011
July 2006
March 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: over the course of the study ] [ Designated as safety issue: No ]
Progression-free survival
Complete list of historical versions of study NCT00372073 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

This is a randomized Phase II study of an experimental anti-cancer drug called seliciclib. The main objective of this study is to learn if, and how long, seliciclib can keep the non-small cell lung cancer in check.

An experimental drug is a drug which has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory agencies for marketing and is still under study to determine how safe it is, what its side-effects are, and whether or not it is effective in the treatment of non-small cell lung cancer.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: seliciclib
    1200 mg bid x 3 days every 2 weeks
  • Drug: placebo
    1200 mg bid x 3 days every 2 weeks
  • Active Comparator: 1
    seliciclib
    Intervention: Drug: seliciclib
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00372073
CYC202-06-14 (A1)
Yes
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Not Provided
Study Chair: Chandra Belani, M.D. Milton S. Hershey Medical Center
Cyclacel Pharmaceuticals, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP