Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370159
Recruitment Status : Withdrawn (Sponsor decided not to move forward)
First Posted : December 12, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 stage IIIB or IV non-small cell lung cancer. Drugs used in chemotherapy, such as CPI-613 and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Condition or disease Intervention/treatment Phase
Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7 Drug: 6,8-Bis(benzylthio)octanoic Acid Drug: Docetaxel Other: Pharmacological Study Phase 1 Phase 2

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 evaluate the response rate in patients receiving CPI-613 in combination with docetaxel therapy. (Phase 2)

SECONDARY OBJECTIVES:

I. To determine the safety of CPI-613 addition to docetaxel therapy. II. To determine the progression-free survival with CPI-613 in combination with docetaxel therapy at 27 weeks.

III. To determine the median progression-free survival with CPI-613 in combination with docetaxel therapy.

OUTLINE: This is a phase I, dose-escalation study of CPI-613 followed by a phase II study.

Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 3, and docetaxel IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients that achieve stable disease after 6 courses then receive CPI-613 alone on days 1and 3. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then periodically for 2 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open-Label Dose Escalation Trial of CPI-613 in Combination With Docetaxel Chemotherapy as a Second-Line Treatment of Non-Small-Cell Lung Cancer
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Treatment (CPI-613, docetaxel)
Patients receive CPI-613 IV over 2 hours on days 1 and 3, and docetaxel IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients that achieve stable disease after 6 courses then receive CPI-613 alone on days 1and 3. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Drug: 6,8-Bis(benzylthio)octanoic Acid
Given IV
Other Names:
  • Alpha-Lipoic Acid Analogue CPI-613
  • CPI 613
  • CPI-613

Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Other: Pharmacological Study
Correlative studies




Primary Outcome Measures :
  1. Phase II dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when administered in combination with a standard dose of docetaxel (Phase 1) [ Time Frame: Up to 18 weeks ]
  2. Response rate defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2) [ Time Frame: Up to 2 years ]
    Will estimate the proportion of patients with a response (complete response + partial response) and calculate a 95% confidence interval for this measure.


Secondary Outcome Measures :
  1. Median progression-free survival (PFS) [ Time Frame: From the start of treatment to the time of progression or death, assessed up to 2 years ]
    Will estimate the median PFS using standard survival methods (Kaplan Meier).

  2. Number and degree of adverse events under the experimental therapy regimens graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 30 days after the last study drug is administered ]
    Will be estimated along with 95% confidence intervals for each adverse event. These estimates will be compared (not using specific statistical tests, but descriptively) to those reported in patients treated with docetaxel.

  3. Overall survival (OS) [ Time Frame: From the start of treatment to date of death, assessed up to 2 years ]
  4. Progression-free survival (PFS) [ Time Frame: From the start of treatment to the time of progression or death, assessed at 27 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370159


Locations
Layout table for location information
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Stefan Grant Wake Forest University Health Sciences
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03370159    
Other Study ID Numbers: IRB00044399
NCI-2017-02010 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 62217 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Thioctic Acid
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances