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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04362748




Registration number
NCT04362748
Ethics application status
Date submitted
23/04/2020
Date registered
27/04/2020

Titles & IDs
Public title
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
Scientific title
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
20180144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 256

Experimental: Dose Escalation Phase - Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.

Experimental: Dose Expansion Phase: Group 1 - Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Experimental: Dose Expansion Phase: Group 2 - Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.


Treatment: Drugs: AMG 256
AMG 256 administered as an intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 2.5 Years
Primary outcome [3] 0 0
Number of Participants with Treatment-Related Adverse Events
Timepoint [3] 0 0
Up to 2.5 Years
Primary outcome [4] 0 0
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Timepoint [4] 0 0
Up to 2 Years
Primary outcome [5] 0 0
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timepoint [5] 0 0
Up to 2 Years
Primary outcome [6] 0 0
Maximum Tolerated Dose (MTD) of AMG 256
Timepoint [6] 0 0
28 days
Primary outcome [7] 0 0
Recommended Phase 2 Dose (RP2D) of AMG 256
Timepoint [7] 0 0
28 days
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of AMG 256
Timepoint [1] 0 0
Up to 2.5 Years
Secondary outcome [2] 0 0
Time to Achieve Cmax (Tmax) of AMG 256
Timepoint [2] 0 0
Up to 2.5 Years
Secondary outcome [3] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of AMG 256
Timepoint [3] 0 0
Up to 2.5 Years
Secondary outcome [4] 0 0
Objective Response (OR)
Timepoint [4] 0 0
Up to 2.5 Years
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to 2.5 Years
Secondary outcome [6] 0 0
Progression-Free Survival (PFS)
Timepoint [6] 0 0
Up to 1 Year
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
Up to 2.5 Years
Secondary outcome [8] 0 0
Duration of Stable Disease
Timepoint [8] 0 0
Up to 2.5 Years
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Up to 2 Years
Secondary outcome [10] 0 0
Number of Participants with anti-AMG 256 Antibodies
Timepoint [10] 0 0
Up to 2.5 Years

Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age = 18 years at the time of signing informed consent.
* Life expectancy of > 3 months, in the opinion of the investigator.
* Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which:
* No standard therapy exists, or
* Standard therapy has failed, not available, or
* In the investigator's opinion, standard therapy does not result in meaningful clinical benefit.
* At least 1 measurable lesion = 10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease.
* History of other malignancy within the past 2 years, with the following Exceptions:
* Malignancy treated with curative intent and with no known active disease present for = 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
* History of solid organ transplantation.
* Major surgery within 28 days of study day 1.
* Live vaccine therapy within 4 weeks prior to study day 1.
* Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Active infection requiring oral or intravenous therapy.
* Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.
* History of severe allergic reactions or severe acute hypersensitivity reaction.
* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG 256.
* Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG 256.
* Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG 256.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG 256.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG 256.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.

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)
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2023
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3168 - Clayton
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
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Spain
State/province [7] 0 0
Cataluña

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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 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.
Available to whom?
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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04362748