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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01653 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 62113 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. To evaluate the safety and anti-cancer activities in patients with relapsed or refractory small cell lung cancer (SCLC) who have failed 1 or 2 lines of chemotherapy.
OUTLINE:
Patients receive CPI-613 intravenously (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.
After completion of study treatment, patients are followed up every 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6,8-bis(benzylthio)octanoic acid | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Survival curves for PFS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year PFS rates will be estimated. Median PFS will be estimated as well. | Up to 3 years |
| Overall survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Each toxicity identified in the protocol will be examined by grade. | Up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Ruiz | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C568850 | devimistat |
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Survival curves for OS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year OS rates will be estimated. Median OS will be estimated as well.
| Up to 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |