Status:
WITHDRAWN
CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IIIB Non-Small Cell Lung Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with docetaxel and to see how well they work in treating patients with st...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerate dose (MTD) of CPI-613 when used in combination with docetaxel therapy in advanced stage non-small cell lung cancer (NSCLC). (Phase1) II. To ev...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed stage IIIB or IV NSCLC with radiographic proof of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Life expectancy of \>= 3 months
- Patients must have received previous systemic therapy to include: a regimen of chemotherapy, immunotherapy including anti-PDL or anti-PD-L1 therapies, combined chemotherapy and immunotherapy, provided treatment was discontinued \>= 2 weeks prior to initiation of treatment on the present protocol
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) within institutional upper limit of normal
- International normalized ratio (INR) =\< 1.5 x upper limit of normal (ULN)
- Prothrombin time (PT) =\< 1.5 x ULN
- Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN or within therapeutic range if receiving anticoagulant therapy OR
- Creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study through 30 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)
Exclusion
- Patients who have had immunotherapy or tyrosine kinase inhibitor (TKI) therapy within two weeks prior to entering the study
- Radiotherapy or prior systemic chemotherapy within 2 weeks
- Patients who have been treated with more than one chemotherapy regimen, immunotherapy regimen or chemotherapy/immunotherapy regimen for metastatic non-small cell lung cancer
- Adverse events resulting from previous therapies have not recovered to grade 1 or less
- Patients may not be receiving any other investigational agents
- Patients with untreated, symptomatic brain metastases should be excluded from this clinical trial (patients with asymptomatic brain metastases amenable to treatment with Gamma Knife radiosurgery \["GKRS"\] are eligible and may receive GKRS while on protocol)
- Lactating females
- Patients with EGFR, ALK or ROS-1 mutations who are eligible for treatment with a TKI and who have not received such treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CPI-613 or docetaxel
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with CPI-613
- Any condition that may, in the opinion of the investigator, compromise the safety of the patient
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03370159
Start Date
June 1 2018
End Date
March 1 2020
Last Update
August 1 2018
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157