Status:
TERMINATED
A Study of Oral Sapacitabine in Patients With Previously Treated 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 II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).
Detailed Description
This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed recurrent NSCLC
- Age of 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to RECIST
- Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- 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
- Patient must be able to swallow capsules
- Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign the informed consent form
Exclusion
- NSCLC histology contains a component of small cell lung cancer
- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
- Pregnant or lactating women
- Known to be HIV-positive
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2013
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00885963
Start Date
December 1 2008
End Date
December 23 2013
Last Update
December 22 2021
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850