Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
- Registration Number
- NCT00372073
- Lead Sponsor
- Cyclacel Pharmaceuticals, Inc.
- Brief Summary
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
- Detailed Description
A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 187
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 with placebo control placebo Randomized to placebo after run-in period. Arm 1 with seliciclib 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.
- Primary Outcome Measures
Name Time Method Progression-free survival over the course of the study Time until the disease starts progressing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Pasco Hernando Oncology
🇺🇸New Port Richey, Florida, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Pacific Coast Hematology Oncology Group
🇺🇸Fountain Valley, California, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Danville Hematology Oncology
🇺🇸Danville, Virginia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Pittsburg Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Center for Oncology Research and Treatment
🇺🇸Dallas, Texas, United States
New Mexico Oncology Hematology Consultants
🇺🇸Albuquerque, New Mexico, United States
University of Maryland, Greenebaun Cancer Center
🇺🇸Baltimore, Maryland, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States