Study to Evaluate Exemestane With and Without SNDX-275 in Treatment of Postmenopausal Women With Advanced Breast Cancer - Full Text View

Sponsor:	Syndax Pharmaceuticals
Information provided by:	Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00676663

Purpose

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.

Condition	Intervention	Phase
Breast Cancer Estrogen Receptor-Positive Breast Cancer Breast Cancer, Estrogen Receptor-Positive ER+ Breast Cancer	Drug: entinostat Drug: exemestane	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane With and Without SNDX-275 in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment With a Non-Steroidal Aromatase Inhibitor

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane MS-275

U.S. FDA Resources

Further study details as provided by Syndax Pharmaceuticals:

Primary Outcome Measures:

To compare the efficacy of exemestane alone with exemestane plus entinostat, as determined by the duration of progression free survival (PFS) measured from the date of randomization. [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare objective response rate (ORR) and clinical benefit rate (CBR)
To evaluate the safety and tolerability of entinostat in combination with exemestane as measured by adverse events and laboratory safety parameters.

Estimated Enrollment:	125
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 exemestane (Aromasin) 25mg daily plus entinostat 5mg PO once/week	Drug: entinostat SNDX-275 5mg tablet PO once/week Drug: exemestane exemestane 25mg PO QD Other Name: Aromasin
Placebo Comparator: 2 exemestane (Aromasin) 25mg daily plus placebo PO once/week	Drug: exemestane exemestane 25mg PO QD Other Name: Aromasin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal female patients
Histologically or cytologically confirmed ER+ breast cancer
Relapsed or progressed on prior treatment with AI
Metastatic disease must be measurable
Patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
Patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior AI
ECOG performance status: 0 to 1
Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 109/L; ANC ≥ 1.5 x 109/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)AST and ALT less than 2.5 times the upper limit of normal for the institution
Able to understand and give written informed consent and comply with study procedures

Exclusion Criteria:

Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting
Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease
Rapidly progressive, life-threatening metastases
Any palliative radiotherapy to the measurable lesion
Previous treatment with SNDX-275 or any other HDAC inhibitor including valproic acid
Allergy to benzamides or inactive components of the study drug
A history of allergies to any active or inactive ingredients of exemestane
Any concomitant medical condition that precludes adequate study treatment compliance
Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
Patient is currently receiving treatment with valproic acid, Zolinza(vorinostat) or any other HDAC inhibitor or DNA methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676663

Show 44 Study Locations

Sponsors and Collaborators

Syndax Pharmaceuticals

Investigators

Principal Investigator:

Denise Yardley, MD

Sarah Cannon Cancer Center

More Information

No publications provided

Responsible Party:	Judy Billingsley, Clinical Program Manager, Syndax Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00676663 History of Changes
Other Study ID Numbers:	SNDX-275-0301
Study First Received:	May 9, 2008
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Syndax Pharmaceuticals:

Breast Neoplasms
Breast Tumor
Mammary Neoplasms

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane

Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012