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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516438

Enrollment

Registered

2007-08-15

Start date

2007-07-31

Completion date

2009-11-30

Last updated

2010-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Tumors

Keywords

malignant solid tumours, Poly(ADP ribose), polymerases

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

Interventions

DRUGKU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUGTopotecan

intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To identify the dose limiting toxicity of the combination therapy	assessed at each visit

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026