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

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied6,8-bis(benzylthio)octanoic acid

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 3, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
Interventions being studied: Drug: 6,8-bis(benzylthio)octanoic acid

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 3, 2018. Always confirm current availability with the study team.

View original record ↗