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

Malignant Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516438
• Other study ID #: KU36-93
• Secondary ID: D0810C00006
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2007
• Last updated: December 7, 2010
• Start date: July 2007
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Solid Tumors
• Neoplasms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral
• Topotecan
intravenous infusion

Locations

Country	Name	City	State
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	KuDOS Pharmaceuticals Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan		assessed at each visit	No
Secondary	To identify the dose limiting toxicity of the combination therapy		assessed at each visit	No