A Randomized, Placebo Controlled Study of ABT-414 combined with Radiation and Temozolomide in Subjects with Newly Diagnosed Glioblastoma with Specific Tumor Markers

• Conditions: ewly diagnosed glioblastoma (GBM) or gliosarcoma; MedDRA version: 18.1Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001166-26-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

1. de novo GBM tumors that test positive for EGFR amplification.
2. Age ? 18 years.
3. Karnofsky performance status ? 70 ? 14 days prior to randomization.
4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
5. Adequate bone marrow, renal, and hepatic function ? 21 days prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. multifocal, recurrent or metatstatic GBM or gliomatosis cerebri.
2. prior chemo therapy or radiosensitizer for cancer of the head and neck region.
3. prior radiotherapy to the head or neck resulting in overlap of radiation fields.
4. prior therapy for glioblastoma or other invasive malignancy.
5. prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified