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

NCT ID: NCT03361358

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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

Conditions

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Advanced Solid Tumors Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agios Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boston, MA

Boston, Massachusetts, United States

Site Status

Nashville, TN

Nashville, Tennessee, United States

Site Status

Barcelona, Spain

Barcelona, , Spain

Site Status

Countries

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United States Spain

Other Identifiers

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AG270-PS-001

Identifier Type: -

Identifier Source: org_study_id

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