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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00885963
• Other study ID #: CYC682-08
• Status: Terminated
• Phase: Phase 2
• Start date: December 1, 2008
• Est. completion date: December 23, 2013

Study information

• Verified date: December 2021
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 23, 2013
• Est. primary completion date: August 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• sapacitabine
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival	Time until disease progression	1.5 years
Secondary	duration of response	Observed response time	1.5 years
Secondary	duration of stable disease	Observed time of the disease state within -30% and +10% of the baseline	1.5 years
Secondary	overall survival	Median survival time of the overall patient population in the study	1.5 years