Stage IIIB Non-Small Cell Lung Cancer AJCC v7Phase 1/2NCT03370159
CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer
A Phase 1/2 study testing 6,8-Bis(benzylthio)octanoic Acid, Docetaxel and Pharmacological Study in people with Stage IIIB Non-Small Cell Lung Cancer AJCC v7 and Stage IV Non-Small Cell Lung Cancer AJCC v7, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- What is being tested?
- 6,8-Bis(benzylthio)octanoic Acid, Docetaxel and Pharmacological Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2018to 1 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Being tested
- 6,8-Bis(benzylthio)octanoic Acid, Docetaxel, Pharmacological Study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6,8-Bis(benzylthio)octanoic AcidDrug
Also called Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613
Given IV
DocetaxelDrug
Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Given IV
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CPI-613, docetaxel) | Experimental | 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. Receives: Drug: 6,8-Bis(benzylthio)octanoic Acid; Drug: Docetaxel; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when administered in combination with a standard dose of docetaxel (Phase 1)
Measured: Up to 18 weeks
Response rate defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)
Will estimate the proportion of patients with a response (complete response + partial response) and calculate a 95% confidence interval for this measure.
Measured: Up to 2 years
Secondary outcomes (4)
Median progression-free survival (PFS)
Will estimate the median PFS using standard survival methods (Kaplan Meier).
Measured: From the start of treatment to the time of progression or death, assessed up to 2 years
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
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.
Measured: Up to 30 days after the last study drug is administered
Overall survival (OS)
Measured: From the start of treatment to date of death, assessed up to 2 years
Progression-free survival (PFS)
Measured: From the start of treatment to the time of progression or death, assessed at 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startJun 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: Sponsor decided not to move forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Non-Small Cell Lung Cancer AJCC v7Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stefan Grant, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370159
- Sponsor's protocol ID
- IRB00044399
- Other IDs
- NCI-2017-02010, CCCWFU 62217, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 4 Dec 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03370159
- Acronym / sponsor ID
- IRB00044399
- Conditions
- Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to move forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CPI-613, docetaxel) | Experimental | Drug: 6,8-Bis(benzylthio)octanoic Acid, Drug: Docetaxel, Other: Pharmacological StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6,8-Bis(benzylthio)octanoic AcidAlso: Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613Given IV | Drug | Treatment (CPI-613, docetaxel) |
| DocetaxelAlso: Docecad, RP56976, Taxotere, Taxotere Injection ConcentrateGiven IV | Drug | Treatment (CPI-613, docetaxel) |
| Pharmacological StudyCorrelative studies | Other | Treatment (CPI-613, docetaxel) |
Primary outcome
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.
4 secondary outcomes
Median progression-free survival (PFS)
Time frame: From the start of treatment to the time of progression or death, assessed up to 2 years
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Grant principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 6,8-Bis(benzylthio)octanoic Acid, Docetaxel and Pharmacological Study in people with Stage IIIB Non-Small Cell Lung Cancer AJCC v7 and Stage IV Non-Small Cell Lung Cancer AJCC v7, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.