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NCT00516724 Clinical Trial

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

Advanced Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00516724
Other study ID # KU36-96
Secondary ID D0810C000042007-
Status Completed
Phase Phase 1
First received
Last updated
Start date June 22, 2007
Est. completion date April 11, 2024

Study information
Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date April 11, 2024
Est. primary completion date January 4, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral
• Carboplatin
intravenous injection
• KU-0059436 (AZD2281)(PARP inhibitor)
Oral
• Paclitaxel
Intravenous injection
• KU-0059436 (AZD2281)(PARP inhibitor)
Oral
• Paclitaxel + Carboplatin
Intravenous injection

Locations
Country Name City State
Belgium Research Site Brussels
Netherlands Research Site Amsterdam
Netherlands Research Site Rotterdam
United Kingdom Research Site London

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin assessed at each visit
Secondary To identify the dose limiting toxicity of the combination therapy assessed at each visit
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