Clinical trial · Interventional
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
NCT00359359CI-TRIAL-00015987completedPhase 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)
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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 |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Sagopilone (BAY86-5302, ZK 219477) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sagopilone and cisplatin
- description
- The study drug sagopilone was administered in combination with a fixed dose of cisplatin
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
- timeFrame
- Phase 1: Baseline up to 3 month of treatment
- measure
- Phase 2: Efficacy measure
- timeFrame
- Phase 2: every 6 weeks after start of treatment
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Small-cell lung cancer * Stage of extensive disease * Adequate function of major organs and systems * Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: * Prior chemotherapy for small-cell lung cancer * Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases * Superior vena cava syndrome or obstruction of any vital structure * Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation * Known allergy or hypersensitivity to platinum-containing drugs * Pregnancy or breast-feeding * Use of any investigational drug within 4 weeks before start of the study
References
Publications (0)
Data not yet available
No reference posted for this study.