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Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

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ClinicalTrials.gov Identifier: NCT02590263
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Glioblastoma Multiforme Radiation: Whole Brain Radiation Drug: Temozolomide Drug: ABT-414 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A of Phase 1 portion
ABT-414 administered every other weeks monotherapy
Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab
  • Mafodotin

Experimental: Phase 2 portion
ABT-414 administered every other weeks in combination with temozolomide
Drug: Temozolomide
Temozolomide will be administered per label.

Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab
  • Mafodotin

Experimental: Arm C of Phase 1 portion
ABT-414 administered every other weeks in combination with radiation and temozolomide
Radiation: Whole Brain Radiation
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.

Drug: Temozolomide
Temozolomide will be administered per label.

Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab
  • Mafodotin

Experimental: Arm B of Phase 1 portion
ABT-414 administered every other weeks in combination with radiation and temozolomide
Radiation: Whole Brain Radiation
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.

Drug: Temozolomide
Temozolomide will be administered per label.

Drug: ABT-414
ABT-414 will be administered by intravenous infusion
Other Names:
  • Depatuxizumab
  • Mafodotin




Primary Outcome Measures :
  1. Percentage of participants with adverse events [ Time Frame: At each visit for approximately 4 years ]
  2. Number of Dose Limiting Toxicities [ Time Frame: At each visit for approximately 1 year ]
    Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.

  3. Progression-free survival [ Time Frame: At each visit for approximately 1 year ]
    Time to progression-free survival is defined as the number of days from the date of first dose to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur (except Arm B and Arm C of Phase 1 portion).

  4. Area under the plasma concentration-time curve (AUC) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects ]
    Assessed during the Phase 1 portion of the study, the area under the plasma concentration-time curve (AUC) is a method of measurement to determine the total exposure of a drug in blood plasma.

  5. Maximum plasma concentration (Cmax) of ABT-414 [ Time Frame: Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects ]
    Assessed during the Phase 1 portion of the study, the maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: At each visit for approximately 1 year ]
    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).

  2. Overall Survival [ Time Frame: At each visit for approximately 1 year ]
    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).

  3. Duration of Overall Response [ Time Frame: At each visit for approximately 1 year ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590263


Contacts
Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com

Locations
Japan
Nagoya University Hospital /ID# 138559 Completed
Nagoya-shi, Aichi, Japan, 466-8560
Iwate Medical University Hospital /ID# 149145 Recruiting
Morioka-shi, Iwate, Japan, 020-8505
Kitasato University Hospital /ID# 148493 Recruiting
Sagamihara-shi, Kanagawa, Japan, 252-0375
Kyoto Prefect Univ Med /ID# 149093 Recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Tohoku University Hospital /ID# 138464 Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Okayama University Hospital /ID# 148674 Recruiting
Okayama-shi, Okayama, Japan, 700-8558
Osaka University Hospital /ID# 140438 Recruiting
Suita-shi, Osaka, Japan, 565-0871
Shizuoka Cancer Center /ID# 148673 Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
National Cancer Center Hospital /ID# 140435 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Kyorin University Hospital /ID# 140360 Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Tokyo Women's Medical University Hospital /ID# 140436 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Chiba Cancer Center /ID# 164375 Recruiting
Chiba, Japan, 260-0801
Saitama Med Univ Int Med Ctr /ID# 140361 Recruiting
Hidaka, Japan, 350-1241
Hiroshima University Hospital /ID# 139399 Recruiting
Hiroshima, Japan, 734-8551
Kumamoto University Hospital /ID# 138558 Recruiting
Kumamoto, Japan, 860-0862
NHO Kyoto Medical Center /ID# 140437 Recruiting
Kyoto, Japan, 612-0861
Osaka Inter. Cancer Institute /ID# 148494 Recruiting
Osaka, Japan, 541-8567
Kyoto University Hospital /ID# 163206 Recruiting
Sakyo-ku, Japan, 606-8507
Hokkaido University Hospital /ID# 150589 Recruiting
Sapporo, Japan, 060-8648
Dokkyo Medical University Hosp /ID# 150990 Recruiting
Shimotsuga, Japan, 321-0293
Nihon University Itabashi Hosp /ID# 149385 Recruiting
Tokyo, Japan, 173-0032
Tsukuba University Hospital /ID# 140433 Recruiting
Tsukuba, Japan, 305-8576
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02590263     History of Changes
Other Study ID Numbers: M13-714
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
WHO grade III
WHO grade IV
Glioblastoma

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents