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Lung CancerPhase 1ENCORE110NCT01594398

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

A Phase 1 study testing entinostat, Erlotinib and Exemestane in people with Lung Cancer and Non Small Cell Lung Cancer (NSCLC), run by Syndax Pharmaceuticals at 3 sites in United States.

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 effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
entinostat, Erlotinib and Exemestane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
May 2012to May 2014
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast Cancer Patients Only
  • Postmenopausal female patients
  • Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and now has current disease progression and is a candidate to receive exemestane
  • NSCLC Patients Only:
  • Cytologically or histologically confirmed NSCLC of stage IIIb or IV
  • Received 1 to 2 prior chemotherapy or chemoradiotherapy regimens for advanced NSCLC (excluding erlotinib and valproic acid) and now has disease progression and is a candidate to receive erlotinib
Show all 10Show fewer
  • All Patients:
  • Age ≥ 18 years
  • Patient must have the following laboratory parameters at study screening: Hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100.0 10-9/L; ANC ≥ 2.0 x 10-9/L; Creatinine less than 2.5 times the upper limit of normal for the institution; AST and alanine transaminase (ALT) < 2.5 times the upper limit of normal for the institution
  • Patients may have a history of brain metastasis as long as certain criteria are met

Who cannot join

  • Pregnant or lactating women
  • Patient has rapidly progressive or life-threatening metastases.
  • Patient has had previous treatment with entinostat or any other HDAC inhibitor including valproic acid
  • Patient has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator, such as but not limited to:
  • MI or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease and a QTc interval > 0.47 seconds.
  • Uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection.
  • Patients with another active cancer (excluding adequately treated basal cell carcinoma or 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase I Study to Assess the Food Effect on the Pharmacokinetics of Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer and Men and Women With Progressive Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®) or erlotinib (Tarceva®). A biomarker (chemical "marker" in the blood/tissue that may be related to your response to the study drug) will also be tested.

Read the detailed description

This is Phase 1, randomized, open-label, study of entinostat. The study is designed to evaluate any food effect on the pharmacokinetics of entinostat.

Patients will be randomized to receive entinostat with or without food on Cycle 1 Day 1 (C1D1). Patients randomized to receive entinostat with food on C1D1 will receive a second dose of entinostat without food on Cycle 1 Day 15 (C1D15). Patients randomized to receive entinostat without food on C1D1 will receive a second dose of entinostat with food on C1D15. Each cycle in the study will be for 28 days duration. Blood samples will be obtained pre-dose and serial blood samples will be taken after each dose to assess pharmacokinetics. For Cycle 2 and all subsequent cycles, all patients will continue to receive entinostat on Days 1 and 15 of each cycle. Those with breast cancer will also receive exemestane orally once daily starting on Cycle 2 Day 1. Those with NSCLC will also receive erlotinib starting on Cycle 2 Day 1.

Patients will be assessed at screening and at pre-prescribed times during study enrollment using standard assessments. Patients will also be assessed for tumor response after each 2 cycles. Patients will continue receiving study treatment until tumor progression or adverse events occur which necessitate discontinuing therapy as determined by the Investigator.

Being tested
entinostat, Erlotinib, Exemestane
Keywords
carcinoma,non small cell lung, lung diseases, lung neoplasms, Respiratory, Carcinoma, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Respiratory Tract Diseases, Erlotinib, Protein Kinase Inhibitors, Breast Neoplasms, Neoplasms, Breast Diseases, Exemestane, Aromatase Inhibitors
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Lung Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • entinostatDrug

    Also called SNDX-275, MS-275

    10 mg, po, q14 days, until progression or intolerable toxicity

  • entinostatDrug

    Also called SNDX-275, MS-275

    10 mg, po, q14 days, until progression or intolerable toxicity

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.

  • ExemestaneDrug

    Also called Aromasin

    Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

  • ExemestaneDrug

    Also called Aromasin

    Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

Study groups in NCT01594398
Study groupRoleWhat they receive
entinostat C1D1 fedExperimentalEntinostat: Beginning C1D1 fed; C1D15 fasted. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Receives: Drug: entinostat; Drug: Erlotinib; Drug: Exemestane
entinostat C1D1 fastedExperimentalEntinostat: Beginning C1D1 fasted; C1D15 fed. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Receives: Drug: entinostat; Drug: Erlotinib; Drug: Exemestane

What is being measured

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

  1. Difference in pharmacokinetics of entinostat when subjects fed or fasted

    The pharmacokinetics of entinostat will be analyzed from patient plasma samples: maximum plasma concentration, time of maximum plasma concentration, area under the plasma concentration-time curve from baseline to last measurable concentration and extrapolated to infinity, terminal elimination rate constant.

    Measured: C1D1 (sequential), D2, 4, 6, 8, 11; C1D15 (sequential), 16, 18, 20, 22 25; C2D1

Secondary outcomes (4)

  1. Change in laboratory values from baseline

    Chemistry, hematology blood samples: changes from baseline will be evaluated.

    Measured: Screening, C1D1, C1D15, C2D1, C3D1

  2. Change in ECG results from baseline

    Changes from baseline will be evaluated including analysis of QTc prolongation and QTc change from baseline.

    Measured: Screening, C1D1 (sequential), D2, 4, 6, 8, 11; C1D15 (sequential), D16, 18, 20, 22, 25; C2D1; EOT

  3. Difference in pharmacodynamics from baseline

    Blood samples will be analyzed for changes from baseline in protein lysine acetylation as measured by peripheral blood monocytes. The food effect, changes after entinostat, and changes after exemestane and erlotinib will be evaluated.

    Measured: C1D1, D2, D8; C1D15, D16, D22; C2D1; C3D1; EOT

  4. Adverse events

    Incidence of treatment emergent adverse events, serious adverse events, adverse events resulting in permanent discontinuation of study drug, and deaths occurring within 30-days of the last dose of study drug.

    Measured: C1D1 , D2, 4, 6, 8, 11; C1D15, 16, 18, 20, 22 25; C2D1; D1 of each subsequent cycle through end of treatment

Timeline

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

  1. First posted9 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2014
  4. Study completionMay 2014

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01594398
Sponsor's protocol ID
SNDX-275-0110
Acronym
ENCORE110
Status last verified
Nov 2021
First submitted
4 May 2012
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
No

Publications

  • Witta SE, Jotte RM, Konduri K, Neubauer MA, Spira AI, Ruxer RL, Varella-Garcia M, Bunn PA Jr, Hirsch FR. Randomized phase II trial of erlotinib with and without entinostat in patients with advanced non-small-cell lung cancer who progressed on prior chemotherapy. J Clin Oncol. 2012 Jun 20;30(18):2248-55. doi: 10.1200/JCO.2011.38.9411. Epub 2012 Apr 16.

    PubMed 22508830

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing entinostat, Erlotinib and Exemestane in people with Lung Cancer and Non Small Cell Lung Cancer (NSCLC), run by Syndax Pharmaceuticals at 3 sites in United States.

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 10 inclusion and 7 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Difference in pharmacokinetics of entinostat when subjects fed or fasted (time frame: C1D1 (sequential), D2, 4, 6, 8, 11; C1D15 (sequential), 16, 18, 20, 22 25; C2D1). 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 NCT01594398, 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 19 Nov 2021.

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