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Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma - Trial NCT01390571

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.

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NCT01390571
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01390571
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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

Study Focus

olaparib

Interventional

drug

Sponsor & Location

Cancer Research UK

Bristol,Cambridge,Manchester,Sutton,Glasgow,Birmingham,Edinburgh, United Kingdom

Timeline & Enrollment

Phase 1

Jul 01, 2011

Jun 20, 2017

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 system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01390571

Non-Device Trial