AzTrials
AzTrials

Advanced Malignant GliomaPhase 2NCT00427440

A Phase II Study to Treat Advanced Malignant Glioma

A Phase 2 study testing AMG 102 at 20 mg/kg and AMG 102 at 10 mg/kg in people with Advanced Malignant Glioma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Glioma
What is being tested?
AMG 102 at 20 mg/kg and AMG 102 at 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
No sites listed yet
Study dates
Nov 2006to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjects with documented histologically confirmed primary grade 4 advanced malignant glioma
  • no more than 3 prior relapses or prior systemic treatments
  • recurrent disease documented by MRI after prior therapy
  • must have at least one site of bidimensionally measurable disease:
  • archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment
  • age ≥ 18 years
Show all 14Show fewer
  • Karnofsky performance score ≥ 60%
  • hemoglobin ≥ 10 g/dL
  • absolute neutrophil count ≥ 1.5 x 10(9th)/L
  • platelet count ≥ 100 x 10(9th)/L
  • serum creatinine ≤ 1.5 times upper limit of normal
  • alanine aminotransferase ≤ 2.5 times upper limit of normal
  • serum total bilirubin ≤ 2.5 times upper limit of normal
  • before any study-specific procedure, the appropriate written informed consent must be obtained

Who cannot join

  • history of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment
  • evidence of acute intracranial/intratumoral hemorrhage; except for subjects with stable grade 1 hemorrhage
  • received radiation therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such therapy
  • treated previously with any c-Met or HGF targeted therapy
  • treated with thalidomide or tamoxifen within 1 week before enrollment or has not recovered from the toxic effects of such cancer therapy
  • treated with immunotherapeutic agents, vaccines or mAb therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such cancer therapy
Show all 29Show fewer
  • treated with alkylating agents within 4 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
  • treated with chemotherapy (non-alkylating agents) within 2 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
  • surgical resection of brain tumor within 4 weeks before enrollment or have not recovered from acute side effects of such therapy, except for neurological effects
  • plans to receive surgery, radiation therapy or other elective surgeries during the course of the study
  • concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study
  • active infection within 7 days before enrollment
  • past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative or adjuvant treatment administered for the last 3 years
  • documented history of human immunodeficiency virus
  • documented history of chronic viral hepatitis
  • concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except:
  • Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium [Lovenox] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed
  • Use of low dose warfarin (< 2 mg/day) for prophylaxis against central venous catheter thrombosis is allowed
  • currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapeutic study(s)
  • had major surgery within 4 weeks before enrollment or recovering from prior surgery
  • known allergy or sensitivity to any of the excipients in the investigational product
  • pregnant or breast feeding
  • unwilling to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product, for:
  • male subjects
  • female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion
  • previously treated with AMG 102
  • previously enrolled into this study
  • will not be available for follow-up assessment
  • has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures

About this study

Official title: A Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.

Being tested
AMG 102 at 20 mg/kg, AMG 102 at 10 mg/kg
Keywords
Glioma, Brain Tumor
Medical subject headings
Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 102 at 20 mg/kgDrug

    AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

  • AMG 102 at 10 mg/kgDrug

    AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

Study groups in NCT00427440
Study groupRoleWhat they receive
AMG 102 at 10 mg/kg Dose LevelExperimentalUp to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
Receives: Drug: AMG 102 at 10 mg/kg
AMG 102 at 20 mg/kg Dose LevelExperimentalUp to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
Receives: Drug: AMG 102 at 20 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment

    Measured: Week 9 from first dose of AMG 102

Secondary outcomes (4)

  1. To assess the safety profile of AMG 102 in subjects with advanced malignant glioma

    Measured: entire study

  2. Estimate overall survival and progression-free survival rates in this population

    Measured: 8 week intervals

  3. Assess the duration of response and time to response in this population

    Measured: Treatment Period

  4. Assess the pharmacokinetics of AMG 102 in subjects with advanced malignant glioma

    Measured: Weeks 1, 5, and 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2008
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00427440
Sponsor's protocol ID
20050253
Status last verified
Apr 2015
First submitted
25 Jan 2007
Last updated
27 Apr 2015
Results posted
No

Publications

  • Wen PY, Schiff D, Cloughesy TF, Raizer JJ, Laterra J, Smitt M, Wolf M, Oliner KS, Anderson A, Zhu M, Loh E, Reardon DA. A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro Oncol. 2011 Apr;13(4):437-46. doi: 10.1093/neuonc/noq198. Epub 2011 Feb 4.

    PubMed 21297127

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 102 at 20 mg/kg and AMG 102 at 10 mg/kg in people with Advanced Malignant Glioma, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment (time frame: Week 9 from first dose of AMG 102). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in