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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00885963
First received: March 31, 2009
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: sapacitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

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 ]

Enrollment: 62
Study Start Date: December 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sapacitabine Drug: sapacitabine
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Chair: Philip Bonomi, M.D. Rush University Medical Center
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00885963     History of Changes
Other Study ID Numbers: CYC682-08
Study First Received: March 31, 2009
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014