Clinical trial · Interventional
Study in Patients With SCLC of Veliparib in Combination With Topotecan
Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
NCT03227016CI-TRIAL-00049676unknownPhase 1ClinicalTrials.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)
Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
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 SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Topo/Veli
- description
- Topotecan and Veliparib in increasing doses
- interventionNames
- Drug: veliparib
- Drug: Topotecan
Primary outcomes (1)
- measure
- adverse events
- timeFrame
- 6 months
- description
- adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be ≥ 18 years of age * Subject with progressive or recurrent ED-SCLC after first line platinum-based therapy, which is either histologically or cytologically confirmed * Performance status (PS) 0-2 ECOG * Adequate bone marrow reserve * Total bilirubin \< 2 x upper limit of normal * AST and ALT \< 2.5 x upper limit of normal, or \< 5 x upper limit of normal in case of liver metastases * Serum creatinine \< 2 x upper limit of normal or creatinine clearance \> 50 ml/min Exclusion Criteria: * Other anti-cancer chemotherapy or radiotherapy * Symptomatic motor or sensory neuro-toxicities CTCAE \> Grade 2 or any other unresolved toxicities from prior systemic anti-cancer therapy or radiotherapy CTCAE \> Grade 1 * Known hypersensitivity to topotecan or veliparib * Brain or meningeal metastasis (unless they are asymptomatic and not requiring systemic corticosteroid therapy) * Major surgery within 6 weeks prior to first treatment on study (subjects must have completely recovered from any previous surgery prior to first treatment on study). * History of cardiac events within the past 3 months * Uncontrolled severe hypertension * Abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess * Uncontrolled nausea / vomiting / diarrhea * Previous malignancy (other than SCLC) in the last 3 years, except basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a prostate carcinoma or superficial bladder tumor \[Ta, Tis and T1\] that was cured in the opinion of the investigator. * History of organ allograft * Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis
References
Publications (0)
Data not yet available
No reference posted for this study.