search
Back to results

CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

Primary Purpose

Recurrent Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
6,8-bis(benzylthio)octanoic acid
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically proven SCLC that has relapsed or been refractory from at least one line of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
  • Expected survival > 1 month
  • No acute toxicities from previous treatment higher than grade 1 at the start of treatment with CPI-613
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
  • Men must practice effective contraceptive methods during the study, unless documentation of infertility exists
  • Platelet count >= 100,000 cells/mm^3 or >= 100 bil/L
  • Absolute neutrophil count (ANC) >= 1500 cells/mm^3 or >= 1.5 bil/L
  • Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper normal limit (UNL)
  • Bilirubin =< 1.5 x UNL
  • Serum creatinine =< 1.5 mg/dL or 133 µmol/L
  • Albumin > 2.0 g/dL or > 20 g/L
  • Mentally competent, ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent form
  • Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements

Exclusion Criteria:

  • Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment
  • Serious medical illness that would potentially increase patients' risk for toxicity
  • Any active uncontrolled bleeding or bleeding diathesis
  • Pregnant women, women of child-bearing potential not using reliable means of contraception, or lactating women
  • Men unwilling to practice contraceptive methods during the study period
  • Life expectancy less than 1 month
  • Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613
  • Patients with untreated central nervous system (CNS) or epidural tumor
  • Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
  • Unwilling or unable to follow protocol requirements
  • Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias not controlled with medication, or symptomatic congestive heart failure
  • Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month
  • Patients with known human immunodeficiency virus (HIV) infection
  • Requirement for immediate palliative treatment of any kind including surgery

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (CPI-613)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
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.

Secondary Outcome Measures

Progression-free survival (PFS)
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)
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.

Full Information

First Posted
August 27, 2013
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01931787
Brief Title
CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Official Title
A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: 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. OUTLINE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (CPI-613)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
6,8-bis(benzylthio)octanoic acid
Other Intervention Name(s)
alpha-lipoic acid analogue CPI-613, CPI-613
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to 3 years
Title
Overall survival (OS)
Description
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.
Time Frame
Up to 3 years
Other Pre-specified Outcome Measures:
Title
Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Description
Each toxicity identified in the protocol will be examined by grade.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven SCLC that has relapsed or been refractory from at least one line of chemotherapy Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 Expected survival > 1 month No acute toxicities from previous treatment higher than grade 1 at the start of treatment with CPI-613 Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation Men must practice effective contraceptive methods during the study, unless documentation of infertility exists Platelet count >= 100,000 cells/mm^3 or >= 100 bil/L Absolute neutrophil count (ANC) >= 1500 cells/mm^3 or >= 1.5 bil/L Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper normal limit (UNL) Bilirubin =< 1.5 x UNL Serum creatinine =< 1.5 mg/dL or 133 µmol/L Albumin > 2.0 g/dL or > 20 g/L Mentally competent, ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent form Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements Exclusion Criteria: Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment Serious medical illness that would potentially increase patients' risk for toxicity Any active uncontrolled bleeding or bleeding diathesis Pregnant women, women of child-bearing potential not using reliable means of contraception, or lactating women Men unwilling to practice contraceptive methods during the study period Life expectancy less than 1 month Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613 Patients with untreated central nervous system (CNS) or epidural tumor Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety Unwilling or unable to follow protocol requirements Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias not controlled with medication, or symptomatic congestive heart failure Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month Patients with known human immunodeficiency virus (HIV) infection Requirement for immediate palliative treatment of any kind including surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Ruiz
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

We'll reach out to this number within 24 hrs