Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
This study has been terminated.
Sponsor:
Cyclacel Pharmaceuticals, Inc.
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
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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 (Adult, Senior) |
| 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
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 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| 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
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:
|
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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016