|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 13, 2007 | ||||||||
| Last Updated Date | September 22, 2009 | ||||||||
| Start Date ICMJE | August 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with gemcitabine | ||||||||
| Change History | Complete list of historical versions of study NCT00515866 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To identify the dose-limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
To identify the dose-limiting toxicity of the combination therapy | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer | ||||||||
| Official Title ICMJE | A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours | ||||||||
| Brief Summary | The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer. Phase II dose has now been determined and the study is now assessing this dose in a Phase II like randomised expansion |
||||||||
| Detailed Description | |||||||||
| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Pancreatic Neoplasms | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms / Comparison Groups | Experimental: Gemcitabine + KU-0059436 | ||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 95 | ||||||||
| Estimated Completion Date | August 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00515866 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | D0810C00005, KU36-29 | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | KuDOS Pharmaceuticals Limited | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | AstraZeneca | ||||||||
| Verification Date | September 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
