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Trial registered on ANZCTR


Registration number
ACTRN12610000092099
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
27/01/2010
Date last updated
13/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
AMP: Phase I/II study of AMG 102 and panitumumab in recurrent Glioblastoma Multiforme (GBM)
Scientific title
AMP: Single arm, phase I/II study to evaluate the six month progression free survival of AMG 102 and panitumumab in recurrent Glioblastoma Multiforme (GBM)
Secondary ID [1] 1341 0
nil
Universal Trial Number (UTN)
Trial acronym
AMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma Multiforme (GBM) 256659 0
Condition category
Condition code
Cancer 256817 256817 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive both AMG 102 and panitumumab, administered by intravenous infusion on day 1 and day 15 of every 28 day treatment cycle, repeated for 6 cycles, unless stopped earlier due to disease progression or unacceptable toxicity. The doses to be used in the phase II component of the study will be determined in the phase I component of the study. The phase I will test doses of AMG 102 of 10 mg/kg and 5 mg/kg, and doses of panitumumab of 6 mg/kg and 4.8 mg/kg.
Intervention code [1] 255895 0
Treatment: Drugs
Comparator / control treatment
This is a single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257683 0
Six month progression free survival (as assessed by Macdonald criteria (Gadolinium-enhanced magnetic resonance imaging (Gd-MRI), steroid use and neurological status).
Timepoint [1] 257683 0
Tumour assessments will be performed at baseline, at the beginning of cycles 2, 3 and 5, at the end of treatment, and then every 2 months until disease progression.
Secondary outcome [1] 263012 0
Toxicity (assessed using physical examination, blood tests, and asking the patient about their health since the last assessment. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0)
Timepoint [1] 263012 0
Adverse events will be assessed at baseline, on day 1 and 15 of every treatment cycle, and 30 days after last study treatment dose.
Secondary outcome [2] 263013 0
Time to disease progression, assessed by Macdonald criteria
Timepoint [2] 263013 0
Tumour assessments will be performed at baseline, at the beginning of cycles 2, 3 and 5, at the end of treatment, and then every 2 months until disease progression.
Secondary outcome [3] 263014 0
Time to treatment failure, assessed by Macdonald criteria
Timepoint [3] 263014 0
Patients will be assessed on day 1 and 15 of every treatment cycle.
Secondary outcome [4] 263015 0
Overall survival, assessed by clinic visits and information available in the patient's medical record
Timepoint [4] 263015 0
Patients will be assessed on day 1 and 15 of every treatment cycle, then 2 monthly during follow up. Follow up will continue until at least 30 days after the last patient ceases study treatment, or until six month progression free survival information is available on all patients, whichever is longer.
Secondary outcome [5] 263016 0
Objective tumour response, assessed by Macdonald criteria
Timepoint [5] 263016 0
Tumour assessments will be performed at baseline, at the beginning of cycles 2, 3 and 5, at the end of treatment, and then every 2 months until disease progression.
Secondary outcome [6] 263017 0
Duration of response, assessed by Macdonald criteria
Timepoint [6] 263017 0
Tumour assessments will be performed at baseline, at the beginning of cycles 2, 3 and 5, at the end of treatment, and then every 2 months until disease progression.

Eligibility
Key inclusion criteria
1. Patients must have clinically or histologically proven recurrent supratentorial glioblastoma (Astrocytoma World Health Organisation (WHO) Grade IV, including GBM subtypes, e.g. gliosarcoma).
2. Measurable disease at either initial diagnosis or at recurrence.
3. >=18 years of age;
4. Tumour tissue specimens must be available;
5. Stable or decreasing dose of steroids for >=7 days prior to registration;
6. Patients must have had prior treatment with radiotherapy and temozolomide;
7. Phase I: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; Phase II: ECOG Performance Status 0-2;
8. Patients must have a mini-mental state examination (MMSE) of >=15;
9. Adequate hepatic, renal and bone marrow function;
10. Written informed consent must be obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with chemotherapy, biologic agents or anti-coagulants within 30 days prior to registration, or prior treatment with an anti-Epidermal Growth Factor Receptor (EGFR) agent at any time;
2. Have had any surgery or brain biopsy within 4 weeks prior to registration or who have not fully recovered from this intervention;
3. History of other malignancy;
4. History of coagulation disorder associated with bleeding;
5. Thrombosis or vascular ischemic events within one year prior to registration;
6. Concurrent illness;
7. Inability to undergo Gd-MRI;
8. Clinically significant cardiovascular disease within one year prior to registration;
9. History of interstitial lung disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled centrally at the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single arm study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 256382 0
Commercial sector/Industry
Name [1] 256382 0
Amgen
Country [1] 256382 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 251696 0
None
Name [1] 251696 0
Address [1] 251696 0
Country [1] 251696 0
Other collaborator category [1] 1064 0
Other Collaborative groups
Name [1] 1064 0
Cooperative Trials Group for Neuro-Oncology
Address [1] 1064 0
COGNO Coordinating Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 1064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258449 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 258449 0
Ethics Coordinator, Cancer Institute NSW, Australian Technology Park, Suite 101, 1 Central Avenue, Eveleigh, NSW 2015
Ethics committee country [1] 258449 0
Date submitted for ethics approval [1] 258449 0
22/01/2010
Approval date [1] 258449 0
18/03/2010
Ethics approval number [1] 258449 0
2010C/02/119

Summary
Brief summary
The purpose of this study is to investigate the effectiveness of a combination of two drugs, called AMG 102 and panitumumab, for patients with brain tumours that have returned after previous treatment. In addition, the study will investigate the side-effects that might be associated with the combination of these two drugs when treating brain tumours.
Research has shown that AMG 102 is effective at treating brain tumours in a small proportion of patients, and preliminary results in the laboratory show that panitumumab could make AMG 102 more effective at treating brain tumours. Therefore this study will be testing this combination of drugs.
The combination of AMG 102 and panitumumab has previously been tested in 8 patients with bowel cancer, and is continuing to be tested in an ongoing bowel cancer study, but has not previously been tested in patients with brain tumours.
Because very few patients have been treated with the combination of AMG 102 and panitumumab, the study will be conducted in two phases. Initially 3 patients will be treated at least one week apart. Once these 3 patients have completed 4 weeks of treatment each, and if there are no concerns with side effects, a further 3 patients will be treated at the same dose. If unacceptable side effects are observed, a lower dose will be tested, again treating 3 patients at least one week apart. If unacceptable side effects are still observed at the lower dose, an even lower dose will be tested.
Using this system, the dose for the second phase will be identified, or if an acceptable dose cannot be identified, the study will not continue.
A total of 6 to 18 patients will participate in the first phase of the study.
The second phase of the study will enrol patients until a total of 42 patients have been treated at the dose identified in the first phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30755 0
Address 30755 0
Country 30755 0
Phone 30755 0
Fax 30755 0
Email 30755 0
Contact person for public queries
Name 14002 0
Michelle Cummins
Address 14002 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 14002 0
Australia
Phone 14002 0
+61 2 9562 5000
Fax 14002 0
Email 14002 0
[email protected]
Contact person for scientific queries
Name 4930 0
Prof Mark Rosenthal
Address 4930 0
c/o- NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 4930 0
Australia
Phone 4930 0
+61 2 9562 5000
Fax 4930 0
Email 4930 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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