Study to Evaluate Erlotinib With or Without SNDX-275 in the Treatment of Patients With Advanced NSCLC
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ClinicalTrials.gov Identifier: NCT00602030 |
Recruitment Status :
Completed
First Posted : January 28, 2008
Last Update Posted : April 19, 2012
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Condition or disease | Intervention/treatment | Phase |
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Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung | Drug: entinostat Drug: SNDX-275 Drug: erlotinib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With NSCLC After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Lead in Open Label Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation
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Drug: entinostat
Dose cohort 1: SNDX-275 5mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles) Dose cohort 2: SNDX-275 10mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles) Drug: erlotinib erlotinib 150mg PO QD
Other Name: Tarceva |
Experimental: 2
erlotinib (Tarceva) and entinostat
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Drug: SNDX-275
entinostat 5mg or 10mg (determined by Lead in study findings) on days 1 and 15 of a 28-day cycle until progression or unacceptable toxicity develops; maximum of 6 cycles Drug: erlotinib erlotinib 150mg PO QD
Other Name: Tarceva |
Placebo Comparator: 3
erlotinib (Tarceva) and matched Placebo patients in this arm who progress will be offered the opportunity to receive SNDX-275 with erlotinib for up to 6 28-day treatment cycles |
Drug: erlotinib
erlotinib 150mg PO QD
Other Name: Tarceva |
- Progression-free survival rate [ Time Frame: 4 months ]
- Progressive-free survival rate [ Time Frame: 6 months ]
- Evaluate safety and tolerability of SNDX-275 in combination with erlotinib [ Time Frame: from date of randomization to discontinuation due to disease progression or intolerable AE ]
- Evaluate pharmacokinetics of SNDX-275 in combination with erlotinib [ Time Frame: From randomization thru day 15 of Cycle 4 of study treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 valporic acid) and progressed based on radiologic evidence
- At least 1 measurable lesion by conventional or spiral CT scan
- 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 109/L; ANC ≥ 1.5 x 109/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 /dL
- AST and 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 CNS involvement
- Prior treatment with an HDAC inhibitor or an 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
- Current use of valporic acid
- 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 IV antibiotics, antivirals, or antifungals within 14 days before study drug administration
- Known 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602030

Principal Investigator: | Samir Witta, MD | Rocky Mountain Cancer Centers | |
Principal Investigator: | Kartik Konduri, MD | Texas Oncology - Sammons Cancer Center | |
Principal Investigator: | Robert Raju, MD | Dayton Oncology |
Responsible Party: | Syndax Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00602030 |
Other Study ID Numbers: |
SNDX-275-0401 |
First Posted: | January 28, 2008 Key Record Dates |
Last Update Posted: | April 19, 2012 |
Last Verified: | April 2012 |
lung cancer NSCLC lung neoplasms respiratory |
Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Erlotinib Hydrochloride Entinostat Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Histone Deacetylase Inhibitors |