AMG 102 and Avastin for Recurrent Malignant Glioma

This study has been completed.

Sponsor:

Collaborator:

Amgen

Information provided by (Responsible Party):

Katy Peters, Duke University Medical Center

ClinicalTrials.gov Identifier:

NCT01113398

First received: April 28, 2010

Last updated: December 9, 2015

Last verified: December 2015

History of Changes

Results First Received: October 21, 2015

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Glioblastoma Multiforme Gliosarcoma
Interventions:	Drug: AMG 102 Drug: Avastin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AMG 102 With Avastin	Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks. AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes. Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Description

AMG 102 With Avastin

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.

AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Participant Flow: Overall Study

	AMG 102 With Avastin
STARTED	36
COMPLETED	36 ^[1]
NOT COMPLETED	0

^[1]	Completed= Discontinued study drug due to disease progression, death, toxicity or any other reason

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
AMG 102 With Avastin	Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks. AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes. Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Description

AMG 102 With Avastin

AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Baseline Measures

	AMG 102 With Avastin
Overall Participants Analyzed [Units: Participants]	36

Age [Units: Years] Mean (Standard Deviation)	53.6 (11.1)

Gender [Units: Participants]
Female	14
Male	22

Outcome Measures

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1. Primary:

Radiographic Response [ Time Frame: 2 years ]

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2. Secondary:

Median Overall Survival (OS) [ Time Frame: 2 years ]

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3. Secondary:

Six-month Progression-free Survival (PFS6) [ Time Frame: 6 months ]

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4. Secondary:

Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities [ Time Frame: 2 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
11/21/14 Amgen notified PI they stopped their own AMG102 studies due to increased risk found in the TX arm on a different study. Dr. Peters decided to stop TX on the 3 current subjects on her study at that time although no increased risks were found.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Katherine B. Peters, MD, PhD
Organization: Duke University Medical Center
phone: 919-684-6173
e-mail: katy.peters@duke.edu

Responsible Party:	Katy Peters, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT01113398 History of Changes
Other Study ID Numbers:	Pro00022491
Study First Received:	April 28, 2010
Results First Received:	October 21, 2015
Last Updated:	December 9, 2015

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