Trial record 1 of 1 for:
ENCORE 301
Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer (ENCORE301)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00676663 |
|
Recruitment Status :
Completed
First Posted : May 13, 2008
Results First Posted : October 24, 2019
Last Update Posted : October 24, 2019
|
Sponsor:
Syndax Pharmaceuticals
Information provided by (Responsible Party):
Syndax Pharmaceuticals
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Estrogen Receptor-Positive Breast Cancer Breast Cancer, Estrogen Receptor-Positive ER+ Breast Cancer | Drug: entinostat Drug: exemestane Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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 |
| Actual Study Start Date : | June 13, 2008 |
| Actual Primary Completion Date : | January 29, 2011 |
| Actual Study Completion Date : | November 26, 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Exemestane
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Exemestane 25 mg + Entinostat 5 mg
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
|
Drug: entinostat
Entinostat 5 mg tablet orally once per week
Other Name: SNDX-275 Drug: exemestane Exemestane 25 mg tablet orally once daily
Other Name: Aromasin® |
|
Placebo Comparator: Exemestane 25 mg + Placebo
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
|
Drug: exemestane
Exemestane 25 mg tablet orally once daily
Other Name: Aromasin® Drug: Placebo Placebo-matching entinostat tablet orally once per week |
Primary Outcome Measures :
- Progression-free Survival (PFS) [ Time Frame: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months) ]PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
Secondary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months) ]ORR is defined as the percentage of participants with response during treatment classified as complete response (CR) or partial response (PR), as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
- Clinical Benefit Rate (CBR) [ Time Frame: From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months) ]CBR is defined as the percentage of participants with overall response (CR + PR) plus stable disease (SD) for 6 months as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years) ]
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs. A TEAE is an AE that starts after the administration of study drug.
A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard.
Other Outcome Measures:
- Overall Survival (OS) [ Time Frame: First dose of study drug to end of study (Median follow-up 24 months in the EE arm and 26.4 months in the EP arm) ]OS was defined as the number of months elapsed between the date of randomization and the date of death (whatever the cause).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal female patients
- Histologically or cytologically confirmed estrogen receptor positive (ER+) breast cancer
- Relapsed or progressed on prior treatment with aromatase inhibitor (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
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
- Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 10^9/L; Absolute Neutrophil Count (ANC ≥) 1.5 x 10^9/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)Aspartate transaminase (AST) and alanine transaminase (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 histone deacetylase (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 deoxyribonucleic acid (DNA) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676663
Locations
Show 38 study locations
Sponsors and Collaborators
Syndax Pharmaceuticals
Investigators
| Principal Investigator: | Denise Yardley, MD | Sarah Cannon Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Syndax Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00676663 |
| Other Study ID Numbers: |
SNDX-275-0301 2009-012623-28 ( EudraCT Number ) |
| First Posted: | May 13, 2008 Key Record Dates |
| Results First Posted: | October 24, 2019 |
| Last Update Posted: | October 24, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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 Entinostat Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Histone Deacetylase Inhibitors |