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Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma

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ClinicalTrials.gov Identifier: NCT03296696
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects with Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: AMG 596 Phase 1

Study Type : Interventional
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Bayesian logistic regression model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose exploration
Dose exploration of the intervention, AMG 596
Drug: AMG 596
Drug

Experimental: Dose expansion
Dose expansion of the intervention, AMG 596
Drug: AMG 596
Drug




Primary Outcome Measures :
  1. Number of subject with treatment-emergent adverse events [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Objective response (OR) as per modified RANO [ Time Frame: 12 month ]
    Objective response (OR) as per modified RANO (Response Assessment in Neuro-Oncology Criteria).

  2. Area under the concentration-time curve (AUC) for serum AMG 596 [ Time Frame: cycle length up to 6 weeks ]
  3. Volume of distribution for serum AMG 596 [ Time Frame: cycle length up to 6 weeks ]
  4. Average steady-state concentration (Css) for serum AMG 596 [ Time Frame: cycle length up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of ≤ 1
  • Life expectancy of at least 3 months, in the opinion of the investigator.
  • Must have pathologically documented, and definitively diagnosed World Health Organization (WHO) grade 4, glioblastoma
  • Must have recurrent disease confirmed by MRI (Group 1) or completed SoC therapy such as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide according to local standards for newly diagnosed disease (Group 2)
  • Renal function and Hepatic function

Exclusion Criteria

  • History or evidence of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) not associated with any antitumor surgery within 6 months before enrolment
  • Known hypersensitivity to immunoglobulins or to any other component of the IP formulation
  • Infection requiring intravenous antibiotics that was completed < 1 week of study enrollment (day 1) with the exemption of prophylactic antibiotics for long line insertion or biopsy
  • Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, e.g., neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for > 2 months) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor
  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or investigational agent) within 14 days (Group 2 subjects) or 5 half-lives (whichever is longer: for Group 1 subjects) of day 1.

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): NCT03296696


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, California
Research Site Recruiting
Los Angeles, California, United States, 90024
Australia, Victoria
Research Site Recruiting
Melbourne, Victoria, Australia, 3000
Germany
Research Site Recruiting
Dresden, Germany, 01307
Research Site Recruiting
Hamburg, Germany, 20246
Research Site Recruiting
Würzburg, Germany, 97080
Netherlands
Research Site Recruiting
Amsterdam, Netherlands, 1081 HV
Spain
Research Site Recruiting
Badalona, Cataluña, Spain, 08916
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03296696     History of Changes
Other Study ID Numbers: 20160132
2017-001658-32 ( EudraCT Number )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Phase 1
EGFRvIII-positive glioblastoma
safety and tolerability
AMG 596

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue