Clinical trial · Interventional
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
NCT00516438CI-TRIAL-00004167completedPhase 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)
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
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 |
|---|---|---|---|
| Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor) | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Topotecan + KU-0059436
- interventionNames
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Drug: Topotecan
Primary outcomes (1)
- measure
- To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
- timeFrame
- assessed at each visit
Secondary outcomes (1)
- measure
- To identify the dose limiting toxicity of the combination therapy
- timeFrame
- assessed at each visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists; * Evaluable disease * Adequate bone marrow, hepatic and renal function Exclusion Criteria: * Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study * Heavily pre treated patient \> 2 previous chemotherapy regimens for metastatic disease * Co-existing active infection
References
Publications (0)
Data not yet available
No reference posted for this study.