Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
NCT ID: NCT00516724
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
189 participants
INTERVENTIONAL
2007-06-22
2024-04-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
NCT00516802
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
NCT00516438
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
NCT04644068
Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours
NCT00633269
Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase
NCT02640755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Carboplatin + KU-0059436
KU-0059436 (AZD2281)(PARP inhibitor)
oral
Carboplatin
intravenous injection
2.
Paclitaxel + KU-0059436
KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Paclitaxel
Intravenous injection
3.
Paclitaxel, Carboplatin + KU-0059436
KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Paclitaxel + Carboplatin
Intravenous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate bone marrow, hepatic and renal function
* Performance status of no more than 2 ( ECOG scale).
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jane Robertson, BSc, MBCHB, MD
Role: STUDY_DIRECTOR
AstraZeneca
Dr Johann de Bono, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Research UK, The Institute of Cancer Research, London, UK
Prof Jan HM Schellens
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute, Amsterdam, The Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Brussels, , Belgium
Research Site
Amsterdam, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, de Bono JS, Schellens JHM. Phase I study of continuous olaparib capsule dosing in combination with carboplatin and/or paclitaxel (Part 1). Invest New Drugs. 2020 Aug;38(4):1117-1128. doi: 10.1007/s10637-019-00856-7. Epub 2019 Oct 30.
van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, de Bono JS, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, De Greve J, Schellens JHM. Phase I study of intermittent olaparib capsule or tablet dosing in combination with carboplatin and paclitaxel (part 2). Invest New Drugs. 2020 Aug;38(4):1096-1107. doi: 10.1007/s10637-019-00857-6. Epub 2019 Oct 21.
Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D0810C00004
Identifier Type: -
Identifier Source: secondary_id
2007-000939-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KU36-96
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.