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Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Triple Negative Metastatic Breast Cancer; Advanced Ovarian Cancer; Carboplatin; Paclitaxel

Intervention: KU-0059436 (AZD2281)(PARP inhibitor) (Drug); Carboplatin (Drug); KU-0059436 (AZD2281)(PARP inhibitor) (Drug); Paclitaxel (Drug); KU-0059436 (AZD2281)(PARP inhibitor) (Drug); Paclitaxel + Carboplatin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Jane Robertson, BSc, MBCHB, MD, Study Director, Affiliation: AstraZeneca
Dr Johann de Bono, MD, Principal Investigator, Affiliation: Cancer Research UK, The Institute of Cancer Research, London, UK
Prof Jan HM Schellens, Principal Investigator, Affiliation: The Netherlands Cancer Institute, Amsterdam, The Netherlands

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 carboplatin and/or Paclitaxel chemotherapy

Clinical Details

Official title: A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours

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

Primary outcome: To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin

Secondary outcome: To identify the dose limiting toxicity of the combination therapy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients with a histologically or cytologically diagnosed malignant

solid tumour

- Adequate bone marrow, hepatic and renal function

- Performance status of no more than 2 ( ECOG scale).

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 and must have recovered from effects

of the major surgery

- More than two previous courses of platinum-containing chemotherapy

- Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive

irradiation leading to bone marrow deficiency) will be excluded from the study

Locations and Contacts

Research Site, Brussels, Belgium

Research Site, Amsterdam, Netherlands

Research Site, Rotterdam, Netherlands

Research Site, Sutton, Surrey, United Kingdom

Additional Information

KU36-96_CSR_Synopsis

Starting date: June 2007
Last updated: July 17, 2015

Page last updated: August 23, 2015

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