Advanced Solid TumorsNCT03361358
Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma
An observational study of Advanced Solid Tumors and Lymphoma, run by Agios Pharmaceuticals, Inc. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- How many people
- 44 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Boston, MA
Boston, Massachusetts, 02114
Nashville, TN
Nashville, Tennessee, 37203
About this study
Official title: 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.
Read the 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
- Conditions
- Advanced Solid Tumors, Lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTAP status in tumors
Number of tumor tissue samples found to have or not have MTAP deletion, as assessed by IHC
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361358
- Sponsor's protocol ID
- AG270-PS-001
- Status last verified
- Mar 2020
- First submitted
- 16 Nov 2017
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT03361358
- Acronym / sponsor ID
- AG270-PS-001
- Conditions
- Advanced Solid Tumors, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumors and Lymphoma, run by Agios Pharmaceuticals, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.