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A071102 -A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation

Trial

Clinical Trial Title

A071102

Trial Status

Open to Enrollment

Start Date

October 31, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Newly Diagnosed Glioblastoma

Eligibility Criteria

Registration Eligibility Criteria Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson Confirmation by central pathology review of WHO Grade IV glioblastoma or gliosarcoma. ECOG Performance Status ≤ 2 Measurable disease or non-measurable disease Extent of resection: Patients with complete resection, partial resection, or biopsy are eligible Progression: Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible Patients deemed to have pseudoprogression are eligible Must have completed standard radiotherapy and concomitant TMZ therapy Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/BCNU wafers), biologics, immunotherapy, or radiation therapy Not pregnant and not nursing

IRB Number

Legacy IRB

Principal Investigator Name

Regan Look, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Tuesday, November 21, 2017 03:48:50 PM