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Breast CancerPhase 1NCT02833155

Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

A Phase 1 study testing Entinostat and Exemestane in people with Breast Cancer, run by Taizhou EOC Pharma Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Entinostat and Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesChina
Study dates
29 Aug 2016to 18 Jul 2018
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 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in the study patients should fulfil the following criteria:
  • Provision of informed consent prior to any study specific procedures.
  • Postmenopausal women aged ≤ 65years.
  • Estrogen receptor (ER) and / or progesterone receptor (PR) positive breast cancer confirmed by pathology.
  • Once received a non-steroidal aromatase inhibitor (letrozole / anastrozole) treatment, the disease recurrence or progression of breast cancer currently.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. And recently (past 2 months), weight loss is no more than 10% of average weight.
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  • Patients must have a life expectancy >3 months.
  • Patients must have adequate organ and bone marrow function as defined by the following laboratory results.
  • .absolute neutrophil count ( ANC )≥ 1,500 /mm3
  • . Platelets≥100,000 /mm3
  • . White blood cell count(WBC） ≥ 3,000 /mm3
  • . Hemoglobin ≥ 9 g/dL.
  • . Creatinine ≤ 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance ≥ 60 ml/min/1.73m2
  • . Total bilirubin ≤ 1.5 times the upper limit of normal for the institution(ULN)
  • .Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 times the upper limit.
  • Patients must be able to take drugs and don't spit out, no malabsorption problem.
  • Able to comply with study procedures and follow-up examinations.

Who cannot join

  • Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month.
  • Previous treatment with entinostat or any other histone deacetylase inhibitor (Valproic acid, Chidamide etc).
  • Known allergy to any ingredients of entinostat and other drugs in the same class.
  • Women who are pregnant or breast-feeding (premenopausal). For women of childbearing potential, agreement to use a medically approved contraception measures (such as the intrauterine device (IUD), birth control pills or condoms) and to continue its use for the duration of study treatment and for 3 months after the last dose of study treatment.
  • Had received chemotherapy/radiotherapy or other anticancer therapy during the study or within 4 weeks of start of study treatment. Patients must completely recovered from all adverse events due to previous agents administered before 4 weeks (except alopecia).
  • Major surgery within 28 days of start of study treatment.
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  • Patients have serious or uncontrolled systemic disease (such as severe liver dysfunction, severe renal dysfunction, poorly controlled diabetes, poorly controlled acute infections). Unstable or decompensated respiratory or cardiovascular disease, or peripheral vascular disease (including diabetic vascular disease), or organ transplantation.
  • Received potent CYP1A2 or CYP3A4 inducer and/or inhibitor (including but not limited following drug: ketoconazole, rifampicin, atazanavir, Clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice, rifabutin, phenytoin, Carbamazepine and phenobarbital).
  • Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [cervical intraepithelial neoplasia （CIN）/cervical carcinoma in situ] or melanoma in-situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
  • Active bleeding or new thrombotic diseases using of anticoagulant drugs, patients with bleeding tendency.
  • Meet with any of the following criteria about cardiac parameters:
  • the corrected QT interval (QTc) >470 msec under resting conditions.
  • myocardial infarction or arterial thrombosis events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease.
  • Resting ECG imply any clinically significant abnormal on rhythm, conduction and morphology, for example, left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec.
  • Any factors (such as, heart failure, hypokalemia, inherited long QT syndrome, acquired long QT syndrome or family history of unexplained sudden death in immediate family members under 40 years old) or known combined drug (such as, sotalol, cisapride, clozapine, amiodarone and erythromycin, etc.) to increase risk of prolongation of QTc interval or arrhythmic event.
  • History of or known human immunodeficiency virus (HIV) infection
  • Known drug or long-term alcoholics.
  • Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study.
  • Involvement in the planning and conduct of the study.
  • Possible of lower inclusion criteria according to the researchers (such as weak, etc), or the other is not suitable for this study.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Cancer Hospital Chinese Academy Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: A Phase I and Pharmacokinetic Study to Evaluate Histone Deacetylase Inhibitor, Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. And to define the profile of adverse events, including laboratory parameters in these subjects

Conditions
Breast Cancer
Being tested
Entinostat, Exemestane
Keywords
entinostat, 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.

  • EntinostatDrug

    Also called MS-275, SDNX-275

    Given PO

  • ExemestaneDrug

    Given PO

Study groups in NCT02833155
Study groupRoleWhat they receive
Entinostat and ExemestaneExperimentalPatients receive entinostat PO on days 1, 8, 15, and 22. Entinostat in combination with exemestane will be repeatedly administered every 28 days in the absence of disease progression or unacceptable toxicity. Exemestane wil be orally administered once daily for up to six months.
Receives: Drug: Entinostat; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination.

    Measured: Up to 28 days

Secondary outcomes (7)

  1. Cmax,maximum plasma concentration

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

  2. tmax,time at which maximum plasma concentration was observed

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

  3. AUC 0-168h area under the plasma concentration-time curve from time zero to 168h

    Measured: Pre-dose, Days 1,2,3,4,5 and 7

  4. AUC 0-inf,area under the plasma concentration-time curve from time zero to infinity

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

  5. T1/2, elimination half-life

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

  6. lambda z , apparent terminal phase elimination constant (λz)

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

  7. MRT，mean residence time

    Measured: Pre-dose, Days 1,2,3,4,5,7,15 and 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study start29 Aug 2016
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02833155
Sponsor's protocol ID
EOC103-001
Status last verified
Jan 2018
First submitted
12 Jul 2016
Last updated
7 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Wang J, Zhang Q, Li Q, Mu Y, Jing J, Li H, Li W, Wang J, Yu G, Wang X, Ouyang Q, Hao J, Lu L, Zhou L, Guan J, Li Q, Xu B. Phase I Study and Pilot Efficacy Analysis of Entinostat, a Novel Histone Deacetylase Inhibitor, in Chinese Postmenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer. Target Oncol. 2021 Sep;16(5):591-599. doi: 10.1007/s11523-021-00823-4. Epub 2021 Jul 1.

    PubMed 34196874

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Entinostat and Exemestane in people with Breast Cancer, run by Taizhou EOC Pharma Co., Ltd. at 4 sites in China.

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 17 inclusion and 20 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: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination. (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833155, which also lists 1 linked publication.

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 7 May 2019.

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