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

March 13, 2020 updated by: Agios Pharmaceuticals, Inc.

Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Barcelona, Spain
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Boston, MA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville, TN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects appropriate for this study will be identified by the Investigators at the study sites based on their clinical judgment. This study may be conducted in subjects who are not currently eligible for an experimental therapy, recognizing that determination of the tumor's MTAP status could be useful in making future decisions about options for treatment.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have a primary CNS malignancy (eg, GBM).
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agios Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG270-PS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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