Clinical trial · Interventional
R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
A Phase II Study of AT-101 in Recurrent Extensive Stage Small Cell Lung Cancer
NCT00773955CI-TRIAL-00014485completedPhase 2Results postedClinicalTrials.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 phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| R-(-)-gossypol acetic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (R-(-)-gossypol)
- description
- Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: R-(-)-gossypol acetic acid
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)
- timeFrame
- During the first 6 courses of treatment
- description
- The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: A Complete Response (CR) requires the disappearance of all target lesions A Partial Response (PR) requires a \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurements.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer * Extensive stage disease * Recurrent disease * Measurable disease * Chemotherapy-sensitive disease, defined as: * No progression during first-line chemotherapy * No disease recurrence \< 2 months after completion of first-line chemotherapy * Must have received prior platinum-based chemotherapy * No symptomatic or progressive brain metastases * Patients with previously treated brain metastases who are clinically and radiographically stable or improved and have been off steroids ≥ 14 days are eligible * ECOG performance status 0-2 * Life expectancy \> 12 weeks * Leukocytes ≥ 3,000/μL * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Total bilirubin \< 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal * Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Hemoglobin \> 8 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 30 days after completion of study therapy * Able to take oral medications on a regular basis * Willing to provide blood samples for mandatory correlative studies * No condition that impairs the ability to swallow and retain R-(-)-gossypol tablets, including the following: * Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * Active peptic ulcer disease * No malabsorption syndrome or disease significantly affecting gastrointestinal function * No ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction * No uncontrolled concurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit compliance with study requirements * No symptomatic hypercalcemia \> grade 2 * No requirement for routine use of hematopoietic growth factors (including G-CSF, GM-CSF, or IL-11) or platelet transfusions to maintain ANC or platelet counts * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to R-(-)-gossypol * No HIV positivity * Recovered from all prior therapy, including prior surgical procedures * No prior surgical procedures affecting absorption * No prior resection of the stomach or small bowel * No more than one prior chemotherapy regimen * No prior racemic gossypol or R-(-)-gossypol * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * At least 4 weeks since prior radiotherapy, hormonal agents, or biologic response modifiers * At least 4 weeks since prior and no concurrent investigational agents or devices * No concurrent prophylactic hematopoietic growth factors (including filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or interleukin-11 \[IL-11\]) during course one * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.