Lung Cancer Clinical Trial

Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC

Summary

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Cytologically or histologically confirmed NSCLC of stage IIIb or IV
Received at least 1 but no more than 2 prior chemotherapy or chemoradiotherapy regimens for advanced NSCLC (that did not include erlotinib and valproic acid) and progressed based on radiologic evidence
At least 1 measurable lesion by conventional or spiral computed tomography (CT) scan
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 and life expectancy of at least 6 months
Paraffin-embedded tumor specimen available for correlative studies
Male or female over 18 years of age
Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 10^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without the use of hematopoietic growth factors
Bilirubin and creatinine less than 2 times the upper limit of normal for the institution
Albumin ≥ 2.5 g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal for the institution
Prothrombin time less than 1.5 times the upper limit of normal for the institution
Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
Willing to use accepted and effective methods of contraception during the study (both men and women as appropriate) and for 3 months after the last dose of SNDX-275
Patient or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) are performed

Exclusion Criteria

Prior stem cell transplant
Clinical evidence of central nervous system (CNS) involvement
Prior treatment with an histone deacetylase (HDAC) inhibitor or an epidermal growth factor receptor (EGFR) inhibitor
Currently taking known inhibitors of CYPA4, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, ≥ 10 mg prednisone, and voriconazole
Currently taking medication(s) on the prohibited medication list
Prior exposure to SNDX-275
Systemic chemotherapy, radiotherapy, or treatment with an investigational agent without recovery to at least grade 1 or baseline before study drug administration
Daily treatment with ≥ 10 mg prednisone within 28 days before study drug administration
Local or whole brain palliative radiotherapy within 14 days before study drug administration
Currently active second malignancy, or any malignancy within the last 5 years other than cured basal or squamous cell skin carcinoma, cervical carcinoma in situ, carcinoma in situ of the bladder, or papillary thyroid cancer
Inability to swallow oral medications or a gastrointestinal malabsorption condition
Acute infection requiring intravenous (IV) antibiotics, antivirals, or antifungals within 14 days before study drug administration
Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection
Another serious or uncontrolled medical condition within 90 days before study drug administration such as acute myocardial infarction, angina, ventricular arrhythmias, hypertension, diabetes mellitus, or renal or hepatic insufficiency
Known hypersensitivity to benzamides
Women who are currently pregnant or breast-feeding
Patient currently is enrolled in (or completed within 28 days before study drug administration) another investigational drug study
Patient has any kind of medical, psychiatric, or behavioral disorder that places the patient at increased risk for study participation or compromises the ability of the patient to give written informed consent and/or to comply with study procedures and requirements

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

141

Study ID:

NCT00602030

Recruitment Status:

Completed

Sponsor:

Syndax Pharmaceuticals

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There is 1 Location for this study

See Locations Near You

HOPE (Hematology Oncology Physicians & Extenders)
Tucson Arizona, , United States
Rocky Mountain Cancer Center
Denver Colorado, , United States
Advanced Medical Specialties
Miami Florida, , United States
Ocala Oncology Center
Ocala Florida, , United States
Cancer Centers of Florida
Ocoee Florida, , United States
Hematology Oncology Associates of Illinois
Chicago Illinois, , United States
Central Indiana Cancer Centers
Indianapolis Indiana, , United States
Kansas City Cancer Centers
Overland Park Kansas, , United States
Alliance Hematology Oncology
Westminster Maryland, , United States
St Joseph Oncology
Saint Joseph Missouri, , United States
The Center for Cancer Care & Research
Saint Louis Missouri, , United States
Mahonig Valley Hematology Oncology Associates
Boardman Ohio, , United States
Dayton Oncology & Hematology
Kettering Ohio, , United States
Oncology Associates of Oregon
Eugene Oregon, , United States
Texas Oncology
Amarillo Texas, , United States
Texas Oncology
Austin Texas, , United States
Texas Oncology
Bedford Texas, , United States
Texas Oncology, Sammons Cancer Center
Dallas Texas, , United States
Texas Oncology
Dallas Texas, , United States
Texas Oncology
Fort Worth Texas, , United States
Texas Oncology
Garland Texas, , United States
Texas Oncology
Longview Texas, , United States
Texas Oncology
Midland Texas, , United States
Texas Oncology
Odessa Texas, , United States
Texas Oncology
Tyler Texas, , United States
Fairfax Northern Virginia Hematology-Oncology
Fairfax Virginia, , United States
Virginia Oncology Associates
Norfolk Virginia, , United States
Highline Medical Oncology
Burien Washington, , United States
Cancer Care Northwest
Spokane Washington, , United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, , United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

141

Study ID:

NCT00602030

Recruitment Status:

Completed

Sponsor:


Syndax Pharmaceuticals

How clear is this clinincal trial information?

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