Small Cell Lung Cancer
Conditions
Keywords
AT101, AT-101, cancer, lung, small-cell, topotecan
Brief summary
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer
Detailed description
Further Study Details provided by Ascenta:
Interventions
DRUGAT-101
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
DRUGtopotecan
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
Sponsors
Ascenta Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible. * Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan * All patients must have measurable disease. * Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities. * ECOG performance status 0-1 * Adequate hematologic function * Adequate liver and renal function * Ability to swallow oral medication
Exclusion criteria
* Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study. * Prior chemotherapy regimen containing irinotecan. * Active secondary malignancy. * Unstable or progressive brain metastases. * Prior history of radiation therapy to \> 25% of the bone marrow. * Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. * Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events. | 13 months |
Secondary
| Measure | Time frame |
|---|---|
| complete or partial remission of disease | 16 months |
Countries
Russia, Ukraine, United States
Outcome results
None listed