CompletedPhase 1

A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Belgium, Netherlands, Poland98 participantsStarted 2005-07-11

Plain-language summary

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: * Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

What they're measuring

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436

Timeframe: assessed at each visit

Trial details

NCT IDNCT00516373

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-12-17

View on ClinicalTrials.gov More Ovarian Neoplasms trials