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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04822298
Registration number
NCT04822298
Ethics application status
Date submitted
26/03/2021
Date registered
30/03/2021
Titles & IDs
Public title
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
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Scientific title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
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Secondary ID [1]
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20180273
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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NSCLC
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 160
Experimental: Part 1: Dose Exploration - The dose exploration part of the study will estimate the MTD and/or the RP2D.
Experimental: Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC - Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
Experimental: Part 2: Dose Expansion - Cohort 2 Squamous NSCLC - Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.
Treatment: Drugs: AMG 160
AMG 160 administered as an intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)
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Assessment method [1]
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DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment.
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Timepoint [1]
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Day 1 to Day 28
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Primary outcome [2]
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Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment.
Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE.
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Timepoint [2]
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Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days
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Secondary outcome [1]
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Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Assessment method [1]
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ORR per modified RECIST v1.1 was defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment.
* CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm.
* PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later.
Exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.
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Timepoint [1]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival (OS) was defined as the time from the date of study Day 1 until death due to any cause. OS time (months) = (date of death - study Day 1 + 1) x 12/365.25.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and percentiles were using Greenwood's formula to estimate the standard error of the landmark estimates using the method by Kalbfleisch and Prentice (1980).
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Timepoint [2]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [3]
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Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1
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Assessment method [3]
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Radiographic PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a radiographic progressive disease (PD) or death from any cause, based on investigator assessment; otherwise, radiographic PFS was censored at the last evaluable tumor assessment date.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
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Timepoint [3]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [4]
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Clinical PFS Per Modified RECIST v1.1
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Assessment method [4]
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Clinical PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a clinical PD or death from any cause, based on investigator assessment; otherwise, clinical PFS was censored at the last evaluable tumor assessment date.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
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Timepoint [4]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [5]
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Time to Response Per Modified RECIST v1.1
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Assessment method [5]
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Time to response per modified RECIST v1.1 was defined as the interval from study Day 1 to the either CR or PR based on investigator assessment.
* CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm.
* PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later.
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Timepoint [5]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [6]
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Time to Progression Per Modified RECIST v1.1
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Assessment method [6]
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Time to progression per modified RECIST v1.1 was defined as the interval from study Day 1 to PD, based on investigator assessment. Time to progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
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Timepoint [6]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [7]
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Time to Clinical Progression
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Assessment method [7]
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Time to clinical progression was defined as the interval from study Day 1 to PD. Time to clinical progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
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Timepoint [7]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [8]
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Duration of Response (DOR) Per Modified RECIST v1.1
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Assessment method [8]
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DOR was defined as the time from the date of an initial objective response per modified RECIST v1.1 to the earlier of soft-tissue progression or death based on investigator assessment.
* CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm.
* PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan.
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Timepoint [8]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Secondary outcome [9]
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Time to Subsequent Therapy
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Assessment method [9]
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Time to subsequent therapy was defined as the time from study Day 1 to the time a participant started/received the subsequent cancer therapy/subsequent therapy; otherwise time to subsequent therapy was censored at the last known date of any of the study assessment prior to initiating the subsequent cancer therapy/subsequent therapy.
Subsequent therapy was defined any anti-cancer therapies intended to treat NSCLC, or any other anti-cancer therapies started after ending study treatment and prior to End of Study.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
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Timepoint [9]
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Median (min, max) time from first dose to end of study was 100 (94, 122) days
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Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
* Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
* With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
* Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* History of hemoptysis within 3 months prior to first dose.
* History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
* Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to start of dosing.
* Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
* Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
* Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
* Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
* Any biological therapy or immunotherapy within 3 weeks of start of first dose.
* Major surgery within 4 weeks of first dose.
* Infection requiring IV antimicrobials for management within 7 days of dosing.
* Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
* Active autoimmune disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/01/2022
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Sample size
Target
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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Austria
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State/province [2]
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Salzburg
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Country [3]
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Austria
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State/province [3]
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Wien
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).
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Trial website
https://clinicaltrials.gov/study/NCT04822298
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/98/NCT04822298/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/98/NCT04822298/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04822298