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
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: seliciclib
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: over the course of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2006
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372073

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Pacific Coast Hematology Oncology Group
Fountain Valley, California, United States, 92708
United States, Florida
Pasco Hernando Oncology
New Port Richey, Florida, United States, 34652
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland, Greenebaun Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
The Family Cancer Center
Collierville, Tennessee, United States, 38017
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Center for Oncology Research and Treatment
Dallas, Texas, United States, 75230
East Texas Medical Center
Tyler, Texas, United States, 75701
United States, Virginia
Danville Hematology Oncology
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Chair: Chandra Belani, M.D. Milton S. Hershey Medical Center
  More Information

No publications provided by Cyclacel Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00372073     History of Changes
Other Study ID Numbers: CYC202-06-14 (A1)
Study First Received: September 3, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Roscovitine
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014