Clinical trial · Interventional
CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)
NCT01931787CI-TRIAL-00033600completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6,8-bis(benzylthio)octanoic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (CPI-613)
- 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.
- interventionNames
- Drug: 6,8-bis(benzylthio)octanoic acid
Primary outcomes (1)
- measure
- Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
- timeFrame
- Up to 3 years
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.