Breast CancerPhase 1NCT00754312
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
A Phase 1 study testing SNDX-275 in people with Breast Cancer, run by Syndax Pharmaceuticals at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SNDX-275
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 28 Feb 2009
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
- Must be able to receive two doses of study medication 7 days apart prior to surgery
- Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR negative histology or triple negative (for ER, PR, HER-2) histology
- Has an ECOG performance status ≤ 2
- Has no clinically significant laboratory or cardiac abnormalities
- Has a negative serum pregnancy test at Screening as is either post menopausal, sterile or willing to use an approved method of contraception.
- Is able to swallow and retain oral medication
Who cannot join
- Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. Bleeding disorders that would increase risks of additional core biopsy for biomarkers b. Morbid obesity
- Is currently receiving treatment with a medication on the prohibited medication list
- Has allergy to benzamides or inactive components of study drug
- Is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.
- Conditions
- Breast Cancer
- Being tested
- SNDX-275
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNDX-275Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ER positive Receives: Drug: SNDX-275 |
| 2 | Experimental | ER negative and/or PR negative histology Receives: Drug: SNDX-275 |
| 3 | Experimental | triple negative histology (for ER, PR, HER-2) Receives: Drug: SNDX-275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
Measured: 14 days
Secondary outcomes (2)
Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits.
Measured: 14 days
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startJun 2008
- Primary completion28 Feb 2009
- Study completion28 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monet Bowling, MD, Principal investigator, Indiana UniversityAndrew Baildam, MD, Study chair, Christie Hospital, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754312
- Sponsor's protocol ID
- SNDX-275-0302
- Status last verified
- Jun 2022
- First submitted
- 15 Sep 2008
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT00754312
- Acronym / sponsor ID
- SNDX-275-0302
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- 28 Feb 2009 (actual)
- Study completion
- 28 Feb 2009 (actual)
- First posted
- 17 Sep 2008 (estimated)
- 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 primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SNDX-275ER positive |
| 2 | Experimental | Drug: SNDX-275ER negative and/or PR negative histology |
| 3 | Experimental | Drug: SNDX-275triple negative histology (for ER, PR, HER-2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
- Must be able to receive two doses of study medication 7 days apart prior to surgery
- Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR negative histology or triple negative (for ER, PR, HER-2) histology
- Has an ECOG performance status ≤ 2
- Has no clinically significant laboratory or cardiac abnormalities
Key exclusion criteria (4 listed)
- Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. Bleeding disorders that would increase risks of additional core biopsy for biomarkers b. Morbid obesity
- Is currently receiving treatment with a medication on the prohibited medication list
- Has allergy to benzamides or inactive components of study drug
- Is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNDX-275 | Drug | 1, 2, 3 |
Primary outcome
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
Time frame: 14 days
2 secondary outcomes
Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits.
Time frame: 14 days
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
Time frame: 14 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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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.
Monet Bowling, MD principal investigator
Indiana University
Andrew Baildam, MD study chair
Christie Hospital, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNDX-275 in people with Breast Cancer, run by Syndax Pharmaceuticals at 1 site in United States.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration (time frame: 14 days). 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 6 Jun 2022.