Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC
NCT ID: NCT00602030
Last Updated: 2022-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
141 participants
INTERVENTIONAL
2008-01-08
2012-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lead-in Phase: Erlotinib + Entinostat 5 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
Entinostat
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Lead-in Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
Entinostat
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Double-blind Phase: Erlotinib + Entinostat 10 mg
Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
Entinostat
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Double-blind Phase: Erlotinib + Placebo
Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
Placebo
Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Crossover Phase: Erlotinib + Entinostat 10 mg
Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
Entinostat
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Interventions
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Entinostat
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Placebo
Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.
Erlotinib
Erlotinib 150 mg tablets once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Syndax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Samir Witta, MD
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Cancer Centers
Kartik Konduri, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Oncology - Sammons Cancer Center
Robert Raju, MD
Role: PRINCIPAL_INVESTIGATOR
Dayton Oncology
Locations
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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
St 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
Countries
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Other Identifiers
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SNDX-275-0401
Identifier Type: -
Identifier Source: org_study_id
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