Status:
TERMINATED
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
Lead Sponsor:
Cyclacel Pharmaceuticals, Inc.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2009
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00372073
Start Date
August 9 2006
End Date
April 7 2009
Last Update
December 22 2021
Active Locations (20)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Pacific Coast Hematology Oncology Group
Fountain Valley, California, United States, 92708
3
Pasco Hernando Oncology
New Port Richey, Florida, United States, 34652
4
Rush University Medical Center
Chicago, Illinois, United States, 60612