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A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Patients With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750698
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : March 18, 2011
Information provided by:
Syndax Pharmaceuticals

Brief Summary:
Preclinical studies have shown that SNDX-275 is able to reactivate the expression of EGFR, E-cadherin and ErbB3 expression. The combination of SNDX-275 with erlotinib (an EGFRi) in patients who are progressing on erlotinib will show measurable activity as evidenced by the disease control rate and with an acceptable safety profile.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: SNDX-275 Drug: erlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Patients With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib
Study Start Date : August 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
"Erlotinib-responsive" patients are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
Drug: SNDX-275
SNDX-275 (10 mg fixed dose PO Q2W) on days 1 and 15 of a 28-day cycle for up to 6 cycles
Other Name: entinostat

Drug: erlotinib
erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
Other Name: Tarceva

Experimental: 2
"Erlotinib-nonresponsive" patients are those who either progressed immediately during treatment with erlotinib (i.e. after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
Drug: SNDX-275
SNDX-275 (10 mg fixed dose PO Q2W) on days 1 and 15 of a 28-day cycle for up to 6 cycles
Other Name: entinostat

Drug: erlotinib
erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
Other Name: Tarceva

Primary Outcome Measures :
  1. Disease control rate (complete response, partial response, or stable disease for at least 3 months) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Progression-free survival rate at 2 months [ Time Frame: 2 months ]
  2. Progression-free survival rate at 4 months [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Cytologically or histologically confirmed NSCLC of stage IIIb (pleural effusion) or IV
  2. Disease is progressing (either no response to treatment or subsequent relapse after an objective response) on erlotinib treatment, based on at least 2 scans (the last being within 4 weeks of study enrollment and can serve as the baseline scan for the patient's screening into the study )
  3. Recovered from any toxicity associated with the most recent cancer treatment (no greater than grade 1 toxicity on CTCAE scale or to prior baseline condition)
  4. At least 1 measurable lesion ≥ 20mm by conventional CT scan or ≥ 10mm by spiral CT scan
  5. ECOG performance score of 0, 1, or 2 and life expectancy of at least 3 months
  6. Paraffin-embedded tumor specimen available for correlative studies
  7. Male or female over 18 years of age
  8. Hemoglobin ≥ 9.0 g/dL; platelets ≥ 75 x 10⁹/L; ANC ≥ 1.0 x 10⁹/L without the use of hematopoietic growth factors
  9. Coagulation tests within the normal range
  10. Bilirubin and creatinine less than 2 times the upper limit of normal for the institution
  11. AST and ALT less than 3 times the upper limit of normal for the institution
  12. Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
  13. 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
  14. Patient or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) is performed


  1. Prior stem cell transplant
  2. Symptomatic CNS involvement
  3. Prior treatment with an HDAC inhibitor
  4. Concurrent anticancer therapy, with the exception of radiotherapy for a non-target study lesion
  5. Currently taking medication(s) on the prohibited medication list
  6. Systemic chemotherapy or treatment with an investigational agent within 28 days before enrollment
  7. Current use of valproic acid
  8. Untreated or unstable brain metastases, or taken steroids for this condition within 4 weeks of study drug administration
  9. 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, or superficial bladder cancer
  10. Inability to swallow oral medications or a gastrointestinal malabsorption condition
  11. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known HIV infection, or active hepatitis B or C infection
  12. Abnormal cardiac function as defined as clinically significant findings on ECG (multifocal PVCs, ST-T wave changes consistent with myocardial infarction or acute ischemia, QTc greater than 500 milliseconds), tachycardia, or left ventricular ejection fraction less than 40% on MUGA scan
  13. Another serious or uncontrolled medical condition within 3 months of enrollment such as hypertension, diabetes mellitus, or suppressed immune system
  14. Known hypersensitivity to benzamides
  15. Morbid obesity
  16. Women who are currently pregnant or breast-feeding
  17. Patient is currently enrolled in (or completed within 28 days) another investigational drug study
  18. Patient unavailable for on-study or follow-up assessments
  19. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00750698

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United States, California
City of Hope
Duarte, California, United States
University of California San Diego
La Jolla, California, United States
Sharp Memorial Hospital
San Diego, California, United States
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States
United States, Illinois
RUSH University Medical Center
Chicago, Illinois, United States
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States
United States, Minnesota
the Mayo Clinic
Rochester, Minnesota, United States
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States
United States, North Carolina
Blumenthal Cancer Center
Charlotte, North Carolina, United States
United States, South Carolina
University of South Carolina
Charleston, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Sponsors and Collaborators
Syndax Pharmaceuticals
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Study Chair: Alex Adjei, MD Roswell Park Cancer Institute
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Responsible Party: Jeannette Hasapidis, Executive Director of Clinical Operations, Syndax Pharmaceuticals, Inc. Identifier: NCT00750698    
Other Study ID Numbers: SNDX-275-0403
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: February 2010
Keywords provided by Syndax Pharmaceuticals:
lung cancer
non small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors