CompletedPhase 1NCT01931787

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.

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

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorWake Forest University Health Sciences
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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.

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