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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361358
• Other study ID #: AG270-PS-001
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: Agios Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Locations

Country	Name	City	State
Spain	Barcelona, Spain	Barcelona
United States	Boston, MA	Boston	Massachusetts
United States	Nashville, TN	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Agios Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of MTAP status in tumors	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