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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02437916




Registration number
NCT02437916
Ethics application status
Date submitted
3/04/2015
Date registered
8/05/2015
Date last updated
6/02/2017

Titles & IDs
Public title
Safety Study of AMG 228 to Treat Solid Tumors
Scientific title
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
20140131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancy 0 0
Advanced Solid Tumors 0 0
Cancer 0 0
Oncology 0 0
Oncology Patients 0 0
Tumors 0 0
Melanoma 0 0
Non-small Cell Lung Cancer 0 0
Squamous Cell Carcinoma of the Head and Neck 0 0
Transitional Cell Carinoma of Bladder 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 228

Experimental: AMG 228 monotherapy - Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.


Treatment: Drugs: AMG 228
AMG 228 will be administered intravenously

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of dose limiting toxicities (DLT)
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Subject incidence of treatment-emergent adverse events
Timepoint [2] 0 0
9 months
Primary outcome [3] 0 0
Subject incidence of treatment-related adverse events
Timepoint [3] 0 0
9 months
Primary outcome [4] 0 0
Subject incidence of clinically significant changes in vital signs and physical assessments
Timepoint [4] 0 0
9 months
Primary outcome [5] 0 0
Subject incidence of clinically significant changes in ECGs
Timepoint [5] 0 0
9 months
Primary outcome [6] 0 0
Subject incidence of clinically significant changes in clinical laboratory tests
Timepoint [6] 0 0
9 months
Primary outcome [7] 0 0
AMG 228 maximum observed concentration (Cmax)
Timepoint [7] 0 0
9 months
Primary outcome [8] 0 0
AMG 228 minimum observed concentration (Cmin)
Timepoint [8] 0 0
9 months
Primary outcome [9] 0 0
AMG 228 area under the concentration-time curve (AUC)
Timepoint [9] 0 0
9 months
Primary outcome [10] 0 0
AMG 228 half-life (t1/2)
Timepoint [10] 0 0
9 months
Secondary outcome [1] 0 0
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Incidence of anti-AMG 228 antibody formation
Timepoint [2] 0 0
9 months
Secondary outcome [3] 0 0
Activation status and changes in numbers of T regulator cells (Treg)
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Subject objective response per immune-related Response Criteria (irRC)
Timepoint [4] 0 0
9 months
Secondary outcome [5] 0 0
Activation status of cytotoxic T lymphocytes (CTL)
Timepoint [5] 0 0
9 months
Secondary outcome [6] 0 0
Changes in numbers of cytotoxic T lymphocytes (CTL)
Timepoint [6] 0 0
9 months

Eligibility
Key inclusion criteria
- Subject must have a pathologically documented, definitively diagnosed, advanced solid
tumor

- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active autoimmune disease, history of autoimmune disease

- Treatment with immune modulators including

- Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors

- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or
investigational agent) within 28 days

- Major surgery within 28 days of study day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
France
State/province [5] 0 0
Villejuif
Country [6] 0 0
Germany
State/province [6] 0 0
Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity,
and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT02437916
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02437916