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

NCT00885963 | Terminated Phase 2

• 1 other identifier: CYC682-08
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• progression-free survival

  1.5 years

• duration of response

  1.5 years

• duration of stable disease

  1.5 years

• overall survival

  1.5 years

Study Arms (1)

sapacitabine

EXPERIMENTAL

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

Interventions

sapacitabine DRUG

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

Also known as: CYC682

sapacitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sapacitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philip Bonomi, M.D.

  Rush University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 22, 2009
• Study Start: December 1, 2008
• Primary Completion: August 13, 2013
• Study Completion: December 23, 2013
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

US (2)