A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
This study has been terminated.
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
First received: March 31, 2009
Last updated: February 7, 2014
Last verified: February 2014
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).
Non-small Cell Lung Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Primary Outcome Measures:
- the rate of response and stable disease [ Time Frame: after cycle 2, 4, 7 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression-free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- duration of response [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- duration of stable disease [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885963
|Rush University Medical Center
|Chicago, Illinois, United States, 60612 |
|Penn State Milton S. Hershey Medical Center
|Hershey, Pennsylvania, United States, 17033-0850 |
Cyclacel Pharmaceuticals, Inc.
||Philip Bonomi, M.D.
||Rush University Medical Center
No publications provided
||Cyclacel Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 31, 2009
||February 7, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases