Clinical Trial: NCT02590263 - My Cancer Genome

NCT02590263

Description:

This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.

Related Conditions:

Malignant Glioma

Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02590263

Trial Eligibility

Document

Title

Brief Title: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Official Title: A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma

Clinical Trial IDs

ORG STUDY ID: M13-714
NCT ID: NCT02590263

Conditions

Malignant Glioma
Glioblastoma Multiforme

Interventions

Drug	Synonyms	Arms
Temozolomide		Arm B of Phase 1 portion
ABT-414	Depatuxizumab, Mafodotin	Arm A of Phase 1 portion

Purpose

Trial Arms

Name	Type	Description	Interventions
Arm A of Phase 1 portion	Experimental	ABT-414 administered every other weeks monotherapy	ABT-414
Phase 2 portion	Experimental	ABT-414 administered every other weeks in combination with temozolomide	Temozolomide ABT-414
Arm C of Phase 1 portion	Experimental	ABT-414 administered every other weeks in combination with radiation and temozolomide	Temozolomide ABT-414
Arm B of Phase 1 portion	Experimental	ABT-414 administered every other weeks in combination with radiation and temozolomide	Temozolomide ABT-414

Eligibility Criteria

        Inclusion Criteria:

          -  Japanese participants with WHO grade III or IV malignant glioma

          -  70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2
             portion

          -  80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion

          -  Adequate bone marrow function

          -  Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2
             portion

          -  Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1
             portion

          -  Participants must have confirmed EGFR amplification by central lab in Phase 2 portion

        Exclusion Criteria:

          -  Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and
             Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2
             portion)

          -  Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion

          -  Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of
             Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion

          -  Participant has a history of major immunologic reaction to any Immunoglobulin G
             containing agents or component of ABT-414.

Maximum Eligible Age:	99 Years
Minimum Eligible Age:	20 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Percentage of participants with adverse events
Time Frame:	At each visit for approximately 4 years
Safety Issue:
Description:	Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.

Secondary Outcome Measures

Measure:	Objective Response Rate
Time Frame:	At each visit for approximately 1 year
Safety Issue:
Description:	The objective response rate is defined as the proportion of participants with at least one measurable lesion at baseline who achieves a confirmed complete (CR) or partial response (PR) based on RANO criteria (except Arm B and Arm C of Phase 1 portion).

Measure:	Overall Survival
Time Frame:	At each visit for approximately 1 year
Safety Issue:
Description:	Overall survival is defined as number of days from the date of first dose to the date of death for all dosed participants (except Arm B and Arm C of Phase 1 portion).

Measure:	Duration of Overall Response
Time Frame:	At each visit for approximately 1 year
Safety Issue:
Description:	The duration of overall response for a given participant is defined as the number of days from the day the RANO criteria are met for CR or PR (whichever is recorded first) to the date that progressive disease (PD) is objectively documented (based RANO criteria) (except Arm B and Arm C of Phase 1 portion).

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	AbbVie

Trial Keywords

WHO grade III
WHO grade IV
Glioblastoma

Last Updated

September 3, 2020

Clinical Trials /

Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma