Non-small Cell Lung Cancer
Conditions
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 in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).
Interventions
DRUGsapacitabine
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of response and stable disease | after cycle 2, 4, 7 and every 3 cycles thereafter | complete response or partial response and stable disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 1.5 years | Time until disease progression |
| duration of response | 1.5 years | Observed response time |
| duration of stable disease | 1.5 years | Observed time of the disease state within -30% and +10% of the baseline |
| overall survival | 1.5 years | Median survival time of the overall patient population in the study |
Countries
United States
Outcome results
None listed