Clinical trial · Interventional
Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen Receptor Breast Cancer | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- entinostat C1D1 fed
- description
- 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.
- interventionNames
- Drug: entinostat
- Drug: Erlotinib
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
- entinostat C1D1 fasted
- description
- 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.
- interventionNames
- Drug: entinostat
- Drug: Erlotinib
- Drug: Exemestane
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 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 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: * 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.
References
Publications (1)
- BACKGROUNDWitta 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. PMID 22508830