Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer
NCT ID: NCT01594398
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2012-05-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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entinostat C1D1 fed
Entinostat: Beginning C1D1 fed; C1D15 fasted. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
entinostat
10 mg, po, q14 days, until progression or intolerable toxicity
Erlotinib
Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
Exemestane
Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
entinostat C1D1 fasted
Entinostat: Beginning C1D1 fasted; C1D15 fed. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
entinostat
10 mg, po, q14 days, until progression or intolerable toxicity
Erlotinib
Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
Exemestane
Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Interventions
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entinostat
10 mg, po, q14 days, until progression or intolerable toxicity
entinostat
10 mg, po, q14 days, until progression or intolerable toxicity
Erlotinib
Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
Erlotinib
Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
Exemestane
Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Exemestane
Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Syndax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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William McCulloch, M.D.
Role: STUDY_DIRECTOR
Syndax Pharmaceuticals
Howard A Burris, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tennessee Oncology
Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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References
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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.
Other Identifiers
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SNDX-275-0110
Identifier Type: -
Identifier Source: org_study_id