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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372073
Recruitment Status : Terminated
First Posted : September 6, 2006
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: seliciclib Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
Study Start Date : July 2006
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
seliciclib
Drug: seliciclib
1200 mg bid x 3 days every 2 weeks

Placebo Comparator: 2 Drug: placebo
1200 mg bid x 3 days every 2 weeks




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: over the course of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372073


Locations
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Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
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Study Chair: Chandra Belani, M.D. Milton S. Hershey Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00372073    
Other Study ID Numbers: CYC202-06-14 (A1)
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Roscovitine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action