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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, Paclitaxel

Interventions: KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin, KU-0059436 (AZD2281)(PARP inhibitor), Paclitaxel, KU-0059436 (AZD2281)(PARP inhibitor)

Countries: Belgium, Netherlands, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (4)

Brussels, Belgium
Amsterdam, Netherlands
Rotterdam, Netherlands
London, United Kingdom