Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan

Phase 1

Completed

• Conditions: Malignant Solid Tumors
• Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Topotecan

• Registration Number: NCT00516438
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-15
• Primary Completion: 2009-03
• Study Completion: 2009-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	KU-0059436 (AZD2281)(PARP inhibitor)	Topotecan + KU-0059436
1	Topotecan	Topotecan + KU-0059436

Primary Outcome Measures

Name	Time	Method
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan	assessed at each visit

Secondary Outcome Measures

Name	Time	Method
To identify the dose limiting toxicity of the combination therapy	assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom