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

A Randomized, Placebo Controlled Phase 3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001166-26-CZ

Enrollment

640

Registered

2015-09-11

Start date

2015-12-28

Completion date

Unknown

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed glioblastoma (GBM) or gliosarcoma MedDRA version: 20.0 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 100000004864

Interventions

Product Name: ABT-414 100 mg Product Code: ABT-414 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: depatuxizumab mafodotin Current Sponsor code: ABT-414 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 ;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;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.	—

Measure

Time frame

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 ;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;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, European Union, France, Germany, Hong Kong, Ireland, Israel, Korea, Republic of, Mexico, Netherlands, New Zealand, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026