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OpenTrials
Completed

NCT Number: NCT00516724

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

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.

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Key information

Conditions

Triple Negative Metastatic Breast Cancer Advanced Ovarian Cancer Carboplatin Paclitaxel

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KU-0059436 (AZD2281)(PARP inhibitor)

Drug

oral

Other names: Olaparib

carboplatin

Drug

intravenous injection

Other names: CBDCA, Paraplatin®

paclitaxel

Drug

Intravenous injection

Paclitaxel + Carboplatin

Drug

Intravenous injection

Primary outcomes

  1. To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin

    Time frame: assessed at each visit

Secondary outcomes

  1. To identify the dose limiting toxicity of the combination therapy

    Time frame: assessed at each visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2024
First posted
Aug 15, 2007
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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