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

Information source: Syndax Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Estrogen Receptor-Positive Breast Cancer; Breast Cancer, Estrogen Receptor-Positive; ER+ Breast Cancer

Intervention: entinostat (Drug); exemestane (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Syndax Pharmaceuticals

Official(s) and/or principal investigator(s):
Denise Yardley, MD, Principal Investigator, Affiliation: Sarah Cannon Cancer Center

Summary

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.

Clinical Details

Official title: A Ph 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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)

Locations and Contacts

Fakultni nemocnice Olomouc, Olomouc, Czech Republic

Radiologicke centrum Multiscan, s.r.o., Pardubice, Czech Republic

Fac Hospital Kralovske, Praque, Czech Republic

National Health Centre of Hungary, Budapest, Hungary

Semmelweis Egyetem, Budapest, Hungary

Radiologicke centrum Multiscan, Debrecen, Hungary

Borsod-Abaus Zemplen County Hospital, Miskolc, Hungary

Clinfan Ltd SMO, County Hospital Szekszard, Szekszárd, Hungary

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation

Blokhin Russian Oncology Research Center of Russian Academy of Medical Sciences, Moscow, Russian Federation

Murmansk Regional Clinical Oncology Dispensary, Murmansk, Russian Federation

Leningrad Regional Oncology Dispensary, Saint-Petersburg, Russian Federation

Stavropol Territory Clinical Oncology Dispensary, Stavropol, Russian Federation

Hematology Oncology Associates, Phoenix, Arizona, United States

California Cancer Care, Greenebrae, California, United States

Moores UCSD Cancer Center, La Jolla, California, United States

University of Colorado, Aurora, Colorado, United States

Rocky Mountain Cancer Center, Denver, Colorado, United States

Hartford Hospital, Hartford, Connecticut, United States

Florida Cancer Specialists, Fort Myers, Florida, United States

Memorial Regional, Hollywood, Florida, United States

Hematology Oncology Associates, Lake Worth, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

Palm Beach Cancer Institute, West Palm Beach, Florida, United States

Medical College of Georgia, Augusta, Georgia, United States

Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States

Indiana University, Indianapolis, Indiana, United States

Greenebaum Cancer Center, Baltimore, Maryland, United States

Kansas City Cancer Center, Kansas City, Missouri, United States

Hematology-Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States

Carolinas Healthcare, Charlotte, North Carolina, United States

Wake Forest University, Winston-Salem, North Carolina, United States

Oncology Hematology Care, Cincinnati, Ohio, United States

RSM Durham Regional Cancer Center - Lakeridge Health, Oshawa, Ontario, Canada

St. Joseph's Health Centre, Toronto, Ontario, Canada

Cancer Centers of the Carolinas, Greenville, South Carolina, United States

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States

Sarah Cannon Cancer Center, Nashville, Tennessee, United States

Longview Cancer Center, Longview, Texas, United States

South Texas Cancer Center, McAllen, Texas, United States

Allison Cancer Center, Midland, Texas, United States

Virginia Cancer Institute, Richmond, Virginia, United States

Columbia Basin Hematology & Oncology, Kennewick, Washington, United States

Puget Sound Cancer Center, Seattle, Washington, United States

Additional Information

Starting date: May 2008
Last updated: March 19, 2014

Page last updated: August 20, 2015

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