Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein
Conditions
Keywords
advanced ovarian cancer, BRCA 1 protein, BRCA 2 protein, Poly(ADP ribose)polymerases
Brief 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
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 | assessed at each visit |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumour response | assessed every 8 weeks |
Countries
Belgium, Netherlands, Poland, United Kingdom
Outcome results
None listed