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

NCT01931787 | Completed Phase 1 FDA Drug

• 4 other identifiers: IRB00024405NCI-2013-01653CCCWFU 62113P30CA012197
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years

Secondary Outcomes (2)

• Progression-free survival (PFS)

  Up to 3 years

• Overall survival (OS)

  Up to 3 years

Other Outcomes (1)

• Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Up to 3 years

Study Arms (1)

Treatment (CPI-613)

EXPERIMENTAL

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

Interventions

6,8-bis(benzylthio)octanoic acid DRUG

Given IV

Also known as: alpha-lipoic acid analogue CPI-613, CPI-613

Treatment (CPI-613)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

devimistat

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jimmy Ruiz

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)