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Clinical Trials List

Protocol NumberPolaris 2015-003
NCT Number(ClinicalTrials.gov Identfier)NCT02709512
Completed

2016-09-19 - 2019-08-23

Phase II/III

Terminated6

ICD-10C45

Mesothelioma

ICD-10C38.8

Malignant neoplasm of overlapping sites of heart, mediastinum and pleura

Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

  • Trial Applicant

  • Sponsor

    POLARIS

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Inn-Wen Chong Division of General Internal Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Min Chen Division of General Internal Medicine
Taipei Veterans General Hospital

Taiwan National PI

陳育民、Heng-Sheng Chao

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Gee-chen Chang Division of General Internal Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator CHIN-CHOU WANG Division of General Internal Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Cheng-Ta Yang Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Inn-Wen Chong 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

CRO

Principal Investigator JANG-MING LEE Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

methothlioma

Objectives

The primary objective of this study is: Determine efficacy as determined by the objective response rate (RR), measured by modified RECIST and RECIST 1.1 criteria (phase 2 portion), and OS (phase 3 portion) 2. The key secondary objective of the phase 2 portion is: Determine the duration of response 3. The key secondary objectives of the phase 3 portion are: • Assess progression free survival (PFS) • Assess the objective response rate • Determine the duration of response

Test Drug

ADI-PEG 20

Active Ingredient

rginine deiminase conjugated to polyethylene glycol 20,000 mw

Dosage Form

Injection

Dosage

3.5 ml

Endpoints

The primary objective of this study is:
Determine efficacy as determined by the objective response rate (RR), measured by
modified RECIST and RECIST 1.1 criteria (phase 2 portion), and OS (phase 3 portion)
2. The key secondary objective of the phase 2 portion is:
Determine the duration of response
3. The key secondary objectives of the phase 3 portion are:
• Assess progression free survival (PFS)
• Assess the objective response rate
• Determine the duration of response

Inclution Criteria

1. Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic
MPM is defined using the World Health Organization’s international histological
classification of tumors as containing an epithelial and a sarcomatoid component with
each component comprising at least 10% of the tumor (Corson 2004, Allen 2005).
2. Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy
study).
3. MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for
study entry at study start, but tumor sample for ASS1 status is required. This study will
employ an adaptive biomarker-driven design with an interim analysis to be conducted at
the end of the phase 2 portion. The interim analysis will evaluate the treatment effect
of ADI-PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in
the overall population (biphasic and sarcomatoid histology patients) and pre-defined
subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus
ASS1-deficiency may be required for the phase 3 portion of the study, pending the
interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples
are not acceptable), will be defined in the laboratory manual. If archived tissue is not
sufficient or not available, then tissue must be obtained by biopsy.
4. Measurable disease as assessed by modified RECIST for MPM for thoracic disease (see
protocol appendix A) and RECIST 1.1 for extra-thoracic disease (see protocol appendix B).
5. ECOG performance status of 0 – 1 (see protocol appendix C).
6. Predicted life expectancy of at least 12 weeks.
7. Age ≥ 18 years (there is no upper age limit).

Exclusion Criteria

1. Radiotherapy (except for palliative reasons) the previous two weeks before.
2. Ongoing toxic manifestations of previous treatments.
3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post
radiotherapy or surgery).
4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
5. Serious infection requiring treatment with intravenous antibiotics at the time of study
entrance, or an infection requiring intravenous therapy within 7 days prior.
6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to
determine possible infection status is not required.
7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure (New York Heart Association Class III or IV),
symptomatic cardiac arrhythmia, previous history of myocardial infarction (unless stable
and good ejection fraction on echocardiogram) or psychiatric illness, and social situations
that would limit compliance with study requirements.
8. Is a participant of, or plans to participate in, another interventional clinical study whilst
taking part in this study. Participation in an observational or biomarker study would be
acceptable, with prior Sponsor approval.
9. Subjects with history of another primary cancer, including co-existent second malignancy,
with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively
treated cervical carcinoma in situ; or c) other primary solid tumor with no known active
disease present in the opinion of the Investigator will not affect patient outcome.
10. Allergy to platinum salts.
11. Pregnancy or lactation.
12. Expected non-compliance.
13. Subjects who had been treated with ADI-PEG 20 previously.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    386 participants

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