Back to resultsA Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sapacitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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
Sites / Locations
- Rush University Medical Center
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sapacitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
the rate of response and stable disease
complete response or partial response and stable disease
Secondary Outcome Measures
progression-free survival
Time until disease progression
duration of response
Observed response time
duration of stable disease
Observed time of the disease state within -30% and +10% of the baseline
overall survival
Median survival time of the overall patient population in the study
Full Information
NCT ID
NCT00885963
First Posted
March 31, 2009
Last Updated
December 7, 2021
Sponsor
Cyclacel Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00885963
Brief Title
A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Official Title
A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Limitation in financial resources.
Study Start Date
December 1, 2008 (Actual)
Primary Completion Date
August 13, 2013 (Actual)
Study Completion Date
December 23, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sapacitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sapacitabine
Other Intervention Name(s)
CYC682
Intervention Description
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
Primary Outcome Measure Information:
Title
the rate of response and stable disease
Description
complete response or partial response and stable disease
Time Frame
after cycle 2, 4, 7 and every 3 cycles thereafter
Secondary Outcome Measure Information:
Title
progression-free survival
Description
Time until disease progression
Time Frame
1.5 years
Title
duration of response
Description
Observed response time
Time Frame
1.5 years
Title
duration of stable disease
Description
Observed time of the disease state within -30% and +10% of the baseline
Time Frame
1.5 years
Title
overall survival
Description
Median survival time of the overall patient population in the study
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Bonomi, M.D.
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
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