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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02709512




Registration number
NCT02709512
Ethics application status
Date submitted
5/03/2016
Date registered
16/03/2016
Date last updated
4/10/2023

Titles & IDs
Public title
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
Scientific title
Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
Secondary ID [1] 0 0
POLARIS2015-003
Universal Trial Number (UTN)
Trial acronym
ATOMIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ADI-PEG 20 plus Pem Platinum
Other interventions - Placebo plus Pem Platinum

Experimental: Drug: ADI-PEG 20 plus Pem Platinum - Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study

In Combination With:

Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous

ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication

Placebo comparator: Drug: Placebo plus Pem Platinum - Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study

In Combination With:

Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous

Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication


Treatment: Drugs: ADI-PEG 20 plus Pem Platinum
Investigational Drug in combination approved standard of care treatment for this indication

Other interventions: Placebo plus Pem Platinum
Placebo in combination approved standard of care treatment for this indication
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response Rate
Timepoint [1] 0 0
approximately 18 months
Primary outcome [2] 0 0
Overall Survival Phase 3 Interim Analysis
Timepoint [2] 0 0
Approximately 18 months
Primary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
18 months
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
approximately 18 months

Eligibility
Key inclusion criteria
* Histologically proven unresectable MPM of biphasic or sarcomatoid histology
* Naïve to chemotherapy or immunotherapy
* ECOG PS 0-1
* Expected survival of at least 3 months
* Age 18 years or over (there is no upper age limit)
* Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
* Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
* Adequate hematologic, hepatic, and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
* History of unstable cardiac disease
* Ongoing toxic manifestations of previous treatments
* Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
* Major thoracic or abdominal surgery from which the patient has not yet recovered.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2022
Sample size
Target
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Tweed Hospital (NNSW LHD) - Tweed Heads
Recruitment hospital [3] 0 0
Princess Alexandria Hospital and Health Services - Woolloongabba
Recruitment hospital [4] 0 0
Southern Adelaide Local Health Network, Inc. - Bedford Park
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2486 - Tweed Heads
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Italy
State/province [10] 0 0
AL
Country [11] 0 0
Italy
State/province [11] 0 0
BG
Country [12] 0 0
Italy
State/province [12] 0 0
GE
Country [13] 0 0
Italy
State/province [13] 0 0
MB
Country [14] 0 0
Italy
State/province [14] 0 0
MI
Country [15] 0 0
Italy
State/province [15] 0 0
PV
Country [16] 0 0
Italy
State/province [16] 0 0
Milan
Country [17] 0 0
Italy
State/province [17] 0 0
Parma
Country [18] 0 0
Italy
State/province [18] 0 0
Pisa
Country [19] 0 0
Taiwan
State/province [19] 0 0
Kaohsiung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taichung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taipei
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taoyuan
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridgeshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Devon
Country [25] 0 0
United Kingdom
State/province [25] 0 0
England
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Hampshire
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Leicestershire
Country [28] 0 0
United Kingdom
State/province [28] 0 0
North Lincolnshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Northumberland
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Oxfordshire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Cardiff
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Edinburgh
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Glasgow
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Leeds
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John S Bomalaski, MD
Address 0 0
Polaris Group
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02709512