A Phase I, Multicenter, Open Label Study on the Effects o... | NCT00754312

Studies
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

NCT00754312

Sponsor

Syndax Pharmaceuticals

Status

Terminated

Last Update Posted

Jun 6, 2022Actual

Enrollment

1Actual

Phase

Phase 1

Conditions

Breast Cancer

Interventions

SNDX-275

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Feb 28, 2009Actual

Completion Date

Feb 28, 2009Actual

First Submitted Date

Sep 15, 2008

First Submission Date that Met QC Criteria

Sep 15, 2008

First Posted Date

Sep 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2022

Last Update Posted Date

Jun 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ER positive	Drug: SNDX-275
2	Experimental	ER negative and/or PR negative histology	Drug: SNDX-275
3	Experimental	triple negative histology (for ER, PR, HER-2)	Drug: SNDX-275

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNDX-275	Drug		1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration		14 days

Secondary Outcomes

Measure	Description	Time Frame
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.		14 days
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Monet Bowling, MD	Indiana University	Principal Investigator
Andrew Baildam, MD	Christie Hospital, UK	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Monet Bowling, MD		Indianapolis	Indiana		United States

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases