A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

  • STATUS
    Recruiting
  • sponsor
    Alliance
Updated on 24 November 2020
temozolomide
glioblastoma

Summary

A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

Description

You are being asked to take part in this study because you have a type of brain tumor called a glioblastoma multiforme (GBM) and you have completed the first part of your treatment with radiation combined with the chemotherapy drug temozolomide (TMZ). The standard treatment after completing radiation is to be treated for 6 months with TMZ chemotherapy given for 5 days every 28 days. MGMT methylation is a test that was already performed as part of your routine care or as part of the screening for A071102.

The purpose of this study is to compare the effects, good or bad of the usual treatment (temozolomide) with or without the addition of the investigational drug veliparib for people whose brain tumors show a change in a small region of DNA (gene) called O6-methylguanine methyltransferase (MGMT). Your tumor showed this change, called MGMT methylation, and researchers want to see if veliparib combined with temozolomide has an effect in your particular type of brain tumor. Veliparib is not approved by the FDA for any type of cancer at this time.

Details
Condition Glioblastoma Multiforme
Clinical Study IdentifierTX143718
SponsorAlliance
Last Modified on24 November 2020

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