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

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

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

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: sapacitabine

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).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sapacitabine; 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; twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days; 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

Collaborators and Investigators

• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Investigators: Study Chair: Philip Bonomi, M.D., Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2008
• Primary Completion (Actual): August 13, 2013
• Study Completion (Actual): December 23, 2013

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: April 21, 2009
• First Posted (Estimate): April 22, 2009

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Sapacitabine
• Other Study ID Numbers: CYC682-08