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

Phase 1

• Conditions: ewly diagnosed glioblastoma (GBM) or gliosarcoma; MedDRA version: 20.0Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 640

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 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

1. multifocal, recurrent or metastatic GBM.
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 except surgery or other invasive malignancy.
5. prior, concomitant or planned treatment with anti-neoplastic intent including but not limited to 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs overall survival (OS) in subjects with newly diagnosed GBM harboring EGFR amplificaton ;Primary end point(s): OS;Timepoint(s) of evaluation of this end point: Imaging to determine PFS performed prior to initiation of adjuvant TMZ and then every 8 weeks thereafter. ;Secondary Objective: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide improves outcomes on the following: PFS, OS for EGFRvIII mutated tumor sub-group, PFS for EGFRvIII mutated sub-group, time to deterioration in neurocognitive functioning, time to deterioration in symptom severity and symptom interference scores of the MDASI-BT questionnaire, OS for the MGMT methylated subgroup

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PFS, OS for EGFRvIII mutated tumor sub-group, PFS for EGFRvIII mutated sub-group, time to deterioration in neurocognitive functioning on the Hopkins Verbal Learning Test Revised (HVLT-R), time to deterioration in symptom severity score (MDASI-BT), time to deterioration on symptom interference score (MDASI-BT), OS for the MGMT methylated subgroup;Timepoint(s) of evaluation of this end point: MRIs will be performed every other cycle, HVLT-R and MDASI-BT performed at screening, prior initiation of adjuvant TMZ, and every 8 weeks thereafter.