Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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)

Next Previous
Trial Profile

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)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Dec 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Pegargiminase (Primary) ; Cisplatin; Pemetrexed
  • Indications Malignant-mesothelioma
  • Focus Registrational; Therapeutic Use
  • Acronyms ATOMIC-Meso
  • Sponsors Polaris Pharmaceuticals

    • Most Recent Events

    • 16 Nov 2023 According to a Polaris Pharmaceuticals media release, when the final portion of the BLA is submitted, Polaris Group will actively seek priority review status for this BLA, which, if granted, could expedite the regulatory review process.
    • 16 Nov 2023 According to a Polaris Pharmaceuticals media release, the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of this trial
    • 04 Oct 2023 Primary endpoint (Response Rate) has not been met as per results published in the ClinicalTrials.gov Trial Registry
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top