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

Completed

• Conditions: Lymphoma; Advanced Solid Tumors

• Registration Number: NCT03361358
• Lead Sponsor: Agios Pharmaceuticals, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Study Start: 2018-03-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of MTAP status in tumors	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

Trial Locations

Locations (3)

Boston, MA; 🇺🇸 Boston, Massachusetts, United States

Nashville, TN; 🇺🇸 Nashville, Tennessee, United States

Barcelona, Spain; 🇪🇸 Barcelona, Spain