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

• Register: EUCTR
• Last refreshed on: 30 May 2022
• Main ID: EUCTR2015-001166-26-AT
• Date of registration: 05/11/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Randomized, Placebo Controlled Study of ABT-414 combined with Radiation and Temozolomide in Subjects with Newly Diagnosed Glioblastoma with Specific Tumor Markers
• Scientific title: 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)
• Date of first enrolment: 17/11/2015
• Target sample size: 640
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001166-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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

Intervention(s)

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 name: ABT-414
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: ABT-414 20 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 name: ABT-414
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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.

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 the MGMT unmethylated group, OS for the MGMT methylated subgroup, 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,

Secondary Outcome(s)

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.

Secondary end point(s): PFS, OS for the MGMT unmethylated and methylated subgroups , time to deterioration in symptom severity score (MDASI-BT), time to deterioration in symptom interference score (MDASI-BT), time to deterioration in verbal memory (HVLT-R) total recall score, OS for the EGFRvIII mutated tumor subgroup, and PFS for the EGFRvIII mutated tumor subgroup

Secondary ID(s)

M13-813

2015-001166-26-CZ

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 14/10/2015
Contact: