Open Label, Dose Escalation Phase I Study of AZD2281
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ClinicalTrials.gov Identifier: NCT00572364 |
Recruitment Status
:
Completed
First Posted
: December 13, 2007
Last Update Posted
: August 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Malignancies | Drug: KU-0059436 (AZD2281)(PARP inhibitor) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | June 2009 |

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Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- The primary objective of this study is to determine the safety and tolerability of AZD2281. [ Time Frame: assessed after each visit ]
- The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. [ Time Frame: assessed after each visit ]

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Ages Eligible for Study: | 20 Years to 74 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists.
Exclusion Criteria:
- Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572364
Japan | |
Research Site | |
Tokyo, Japan |
Study Director: | James Carmichael | KuDOS/AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00572364 History of Changes |
Other Study ID Numbers: |
D0810C00001 |
First Posted: | December 13, 2007 Key Record Dates |
Last Update Posted: | August 20, 2009 |
Last Verified: | August 2009 |
Keywords provided by AstraZeneca:
Cancer Advanced solid malignancies |
Additional relevant MeSH terms:
Neoplasms Poly(ADP-ribose) Polymerase Inhibitors Olaparib |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |