A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein
Both
Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein
Trial Information
A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.
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).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436
Outcome Time Frame:
assessed at each visit
Safety Issue:
No
Principal Investigator
Jane Robertson, BSc, MBCHB, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
D0810C00002
NCT ID:
NCT00516373
Start Date:
July 2005
Completion Date:
December 2012
Related Keywords:
- Ovarian Neoplasms
- BRCA1 Protein
- BRCA2 Protein
- advanced ovarian cancer
- BRCA 1 protein
- BRCA 2 protein
- Poly(ADP ribose)polymerases
- Neoplasms
- Ovarian Neoplasms
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