This trial is active, not recruiting.

Conditions triple negative metastatic breast cancer, advanced ovarian cancer, carboplatin, paclitaxel
Treatments ku-0059436 (azd2281)(parp inhibitor), carboplatin, paclitaxel, paclitaxel + carboplatin
Phase phase 1
Sponsor AstraZeneca
Start date June 2007
End date January 2013
Trial size 192 participants
Trial identifier NCT00516724, D0810C00004, KU36-96


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Carboplatin + KU-0059436
ku-0059436 (azd2281)(parp inhibitor) Olaparib
carboplatin CBDCA
intravenous injection
Paclitaxel + KU-0059436
ku-0059436 (azd2281)(parp inhibitor) Olaparib
Intravenous injection
Paclitaxel, Carboplatin + KU-0059436
ku-0059436 (azd2281)(parp inhibitor) Olaparib
paclitaxel + carboplatin
Intravenous injection

Primary Outcomes

To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
time frame: assessed at each visit

Secondary Outcomes

To identify the dose limiting toxicity of the combination therapy
time frame: assessed at each visit

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

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
Principal investigator Dr Johann de Bono, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.