Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pancreatic Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00515866

KU36-29

D0810C00005

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 gemcitabine chemotherapy for the treatment of pancreatic cancer.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of pancreas
• Locally advanced or metastatic unresectable disease

Exclusion criteria

• No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 1 patient group

1

Experimental group

Description:

Gemcitabine + KU-0059436

Treatment:

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

Drug: Gemcitabine