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NCT01390571

Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma

A Cancer Research UK Phase I Trial of Olaparib (AZD2281), an Oral PARP Inhibitor, in Combination With Extended Low-Dose Oral Temozolomide in Patients With Relapsed Glioblastoma
Cancer Research UK·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
olaparib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Cancer Research UK
Location
Bristol,Cambridge,Manchester,Sutton,Glasgow,Birmingham,Edinburgh, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Jul 01, 2011
End date
Jun 20, 2017
Enrollment
34 participants
Primary outcome

Detection of olaparib in tumor tissue using liquid chromatography mass spectrometry (LC-MS) seen in at least 1 out of the 6 patients treated in stage 1 of the study,Maximum-tolerated dose of olaparib in combination with temozolomide (stage 2),Toxicity profile and dose-limiting toxicity as assessed by NCI CTCAE Version 4.02 (stage 2)

Summary

RATIONALE: Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed
 for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to
 stop the growth of tumor cells, either by killing the cells or by stopping them from
 dividing. Olaparib may help temozolomide kill more tumor cells by making tumor cells more
 sensitive to the drug.
 
 PURPOSE: This phase I trial is studying the side effects and best dose of olaparib and
 temozolomide in treating patients with relapsed glioblastoma.

ICD-10 classifications
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01390571
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01390571 through Pure Global AI's free database. This Phase 1 trial is sponsored by Cancer Research UK and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 34 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.