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Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

NCT02029573 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-18

No results posted yet for this study

Summary

The purpose of this study is to explore the efficacy and safety of Atorvastatin in combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The anticipated time on study treatment is until disease progression, and the target sample size is 32 individuals.

Conditions

Interventions

DRUG

Atorvastatin

80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)

DRUG

Temozolomide

75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy

RADIATION

Radiotherapy

60 Gy in 30 fractions

Sponsors & Collaborators

  • King Fahad Medical City

    lead OTHER_GOV

Principal Investigators

  • Abdullah K. Altwairgi, MD · King Fahad Medical City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029573 on ClinicalTrials.gov