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Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709512
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Polaris Group

Brief Summary:
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: ADI-PEG 20 plus Pem Cis Other: Placebo plus Pem Cis Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Drug: ADI-PEG 20 plus Pem Cis

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

Drug: ADI-PEG 20 plus Pem Cis
Investigational Drug in combination approved standard of care treatment for this indication
Other Names:
  • Pemetrexed
  • Cisplatin

Placebo Comparator: Drug: Placebo plus Pem Cis

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

Other: Placebo plus Pem Cis
Placebo in combination approved standard of care treatment for this indication
Other Names:
  • Pemetrexed
  • Cisplatin




Primary Outcome Measures :
  1. Response Rate [ Time Frame: approximately 18 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: approximately 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709512


Contacts
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Contact: Sonia Doyle 858-452-6688 ext 189 sdoyle@polarispharma.com
Contact: Sandra Dodd 858-452-6688 ext 188 sdodd@polarispharma.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
Polaris Group
Investigators
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Study Director: John S Bomalaski, MD Polaris Group
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Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT02709512    
Other Study ID Numbers: POLARIS2015-003
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polaris Group:
Malignant Pleural Mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors