Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
NCT ID: NCT00372073
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
187 participants
INTERVENTIONAL
2006-08-09
2009-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1 with seliciclib
Oral seliciclib at 1200mg b.i.d. for 3 consecutive days as an outpatient beginning on day 1 every 2 weeks for 3 cycles as run-in. Patients (randomized) continue on treatment if derived clinical benefit during run-in period.
seliciclib
1200 mg bid x 3 days every 2 weeks
Arm 2 with placebo control
Randomized to placebo after run-in period.
placebo
1200 mg bid x 3 days every 2 weeks
Interventions
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seliciclib
1200 mg bid x 3 days every 2 weeks
placebo
1200 mg bid x 3 days every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cyclacel Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chandra Belani, M.D.
Role: STUDY_CHAIR
Milton S. Hershey Medical Center
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Pacific Coast Hematology Oncology Group
Fountain Valley, California, United States
Pasco Hernando Oncology
New Port Richey, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
University of Maryland, Greenebaun Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, United States
The Family Cancer Center
Collierville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Center for Oncology Research and Treatment
Dallas, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
Danville Hematology Oncology
Danville, Virginia, United States
Countries
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References
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Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
Other Identifiers
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CYC202-06-14 (A1)
Identifier Type: -
Identifier Source: org_study_id