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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516373
First received: August 13, 2007
Last updated: October 3, 2014
Last verified: October 2014

August 13, 2007
October 3, 2014
July 2005
December 2008   (final data collection date for primary outcome measure)
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436
Complete list of historical versions of study NCT00516373 on ClinicalTrials.gov Archive Site
Objective tumour response [ Time Frame: assessed every 8 weeks ] [ Designated as safety issue: No ]
Objective tumour response
Not Provided
Not Provided
 
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Neoplasms
  • BRCA1 Protein
  • BRCA2 Protein
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Experimental: KU-0059436
KU-0059436 administered orally twice daily
Intervention: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
95
December 2014
December 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands,   Poland,   United Kingdom
 
NCT00516373
KU36-92, D0810C00002
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Dr. Johann De Bono, PhD MRCP FRCR Royal Marsden Hospital Trust, London, UK
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP