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

Sponsor
Cyclacel Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00885963
Collaborator
(none)
62
Enrollment
2
Locations
1
Arm
60.7
Actual Duration (Months)
31
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Actual Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Aug 13, 2013
Actual Study Completion Date :
Dec 23, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the rate of response and stable disease [after cycle 2, 4, 7 and every 3 cycles thereafter]

      complete response or partial response and stable disease

    Secondary Outcome Measures

    1. progression-free survival [1.5 years]

      Time until disease progression

    2. duration of response [1.5 years]

      Observed response time

    3. duration of stable disease [1.5 years]

      Observed time of the disease state within -30% and +10% of the baseline

    4. overall survival [1.5 years]

      Median survival time of the overall patient population in the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Chicago Illinois United States 60612
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyclacel Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00885963
    Other Study ID Numbers:
    • CYC682-08
    First Posted:
    Apr 22, 2009
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Sapacitabine

    Study Results

    No Results Posted as of Dec 22, 2021