CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
This pilot clinical trial studies CPI-613 (6,8-bis[benzylthio]octanoic acid) in treating patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the growth of tumor cells and may be an effective treatment for small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)|
- Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The proportion of responders as the percent of patients who are SD, PR and CR will be estimated, as well as RR (sum of PR + CR) and disease control rate (DCR, which is the sum of SD, PR and CR). 95% confidence intervals will be included.
- Progression-free survival (PFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Survival curves for PFS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year PFS rates will be estimated. Median PFS will be estimated as well.
- Overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Survival curves for OS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year OS rates will be estimated. Median OS will be estimated as well.
- Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Each toxicity identified in the protocol will be examined by grade.
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (CPI-613)
Patients receive CPI-613 IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: 6,8-bis(benzylthio)octanoic acid
I. To evaluate the safety and anti-cancer activities in patients with relapsed or refractory small cell lung cancer (SCLC) who have failed 1 or 2 lines of chemotherapy.
Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01931787
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Thomas Freeman, PA-C 336-713-6914 firstname.lastname@example.org|
|Principal Investigator: Jimmy Ruiz|
|Principal Investigator:||Jimmy Ruiz||Comprehensive Cancer Center of Wake Forest University|