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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Malignant Solid Tumors

Treatments: Drug: Topotecan; Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516438

KU36-93

D0810C00006

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

1

Experimental group

Description:

Topotecan + KU-0059436

Treatment:

Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Drug: Topotecan