CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03370159|
Recruitment Status : Withdrawn (Sponsor decided not to move forward)
First Posted : December 12, 2017
Last Update Posted : August 1, 2018
|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|
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)
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Other: Pharmacological Study
- 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 ]
- 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.
- 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).
- 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.
- Overall survival (OS) [ Time Frame: From the start of treatment to date of death, assessed up to 2 years ]
- Progression-free survival (PFS) [ Time Frame: From the start of treatment to the time of progression or death, assessed at 27 weeks ]
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
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stefan Grant||Wake Forest University Health Sciences|