A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Study Overview
=================
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).

Official Title
-----------------
A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: sapacitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sapacitabine<br>Part A (lead-in phase): Two dosing schedules, i.e., once daily (q.d.) or twice daily (b.i.d.) x 5 days/week x 2 weeks every 3 weeks will be evaluated. Part B (Phase 2): Receive the recommended phase 2 dose of once daily or twice daily dosing schedule derived from Part A. | Drug: sapacitabine<br>* twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days<br>* Other names: CYC682;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of response and stable disease | complete response or partial response and stable disease | after cycle 2, 4, 7 and every 3 cycles thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Time until disease progression | 1.5 years | 
| duration of response | Observed response time | 1.5 years | 
| duration of stable disease | Observed time of the disease state within -30% and +10% of the baseline | 1.5 years | 
| overall survival | Median survival time of the overall patient population in the study | 1.5 years |