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Completed

NCT Number: NCT03361358

Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma

The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.

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Key information

Conditions

Advanced Solid Tumors Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barcelona, Spain, Barcelona, Spain

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About this study

Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein.

Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be ≥18 years of age.
  • Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma.
  • Have archival tumor tissue that can be provided for assessment of MTAP deletion status.
  • Have given written informed consent to participate in this study.

Exclusion criteria

  • Have a primary CNS malignancy (eg, GBM).
  • Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.

Treatment and study plan

Primary outcomes

  1. Determination of MTAP status in tumors

    Time frame: From initiation of the Pre-Screen study until the Phase 1 study of AG-270 is activated at each study site, up to 9 months

    Number of tumor tissue samples found to have or not have MTAP deletion, as assessed by IHC

Sponsors and collaborators

Lead sponsor

Agios Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With Advanced Solid Tumors or Lymphoma

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2017
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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