Clinical trial · Interventional
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy
NCT00397293CI-TRIAL-00003829completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AT-101 | Drug | — | UNRESOLVED |
| topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with adverse events.
- timeFrame
- 13 months
Secondary outcomes (1)
- measure
- complete or partial remission of disease
- timeFrame
- 16 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.