Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cytologically or histologically confirmed NSCLC of stage IIIb (pleural effusion) or IV
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 participant's screening into the study)
Recovered from any toxicity associated with the most recent cancer treatment (no greater than grade 1 toxicity on Common Terminology Criteria for Adverse Events scale or to prior baseline condition)
At least 1 measurable lesion ≥ 20 millimeters (mm) by conventional computed tomography (CT) scan or ≥ 10 mm by spiral CT scan
Eastern Cooperative Oncology Group performance score of 0, 1, or 2 and life expectancy of at least 3 months
Paraffin-embedded tumor specimen available for correlative studies
Male or female over 18 years of age
Hemoglobin ≥ 9.0 grams/deciliter; platelets ≥ 75 x 10^9/liter (L); absolute neutrophil count ≥ 1.0 x 10^9/L without the use of hematopoietic growth factors
Coagulation tests within the normal range
Bilirubin and creatinine less than 2 times the upper limit of normal for the institution
Aspartate aminotransferase and alanine aminotransferase less than 3 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 entinostat
Participant or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) is performed

Exclusion Criteria:

Prior stem cell transplant
Symptomatic central nervous system involvement
Prior treatment with an histone deacetylase inhibitor
Concurrent anticancer therapy, with the exception of radiotherapy for a non-target study lesion
Currently taking medication(s) on the prohibited medication list
Systemic chemotherapy or treatment with an investigational agent within 28 days before enrollment
Current use of valproic acid
Untreated or unstable brain metastases, or taken steroids for this condition within 4 weeks of 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, or superficial bladder cancer
Inability to swallow oral medications or a gastrointestinal malabsorption condition
Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection
Abnormal cardiac function as defined as clinically significant findings on electrocardiogram (multifocal premature ventricular complexes, 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 multigated acquisition scan
Another serious or uncontrolled medical condition within 3 months of enrollment such as hypertension, diabetes mellitus, or suppressed immune system
Known hypersensitivity to benzamides
Morbid obesity
Women who are currently pregnant or breast-feeding
Participant is currently enrolled in (or completed within 28 days) another investigational drug study
Participant unavailable for on-study or follow-up assessments
Participant has any kind of medical, psychiatric, or behavioral disorder that places the participant at increased risk for study participation or compromises the ability of the participant to give written informed consent and/or to comply with study procedures and requirements

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00750698

Recruitment Status:

Terminated

Sponsor:

Syndax Pharmaceuticals

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There are 4 Locations for this study

See Locations Near You

Sharp Clinical Oncology Research
San Diego California, 92123, United States
University of Miami
Miami Florida, 33136, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Roswell Park Cancer Institute
Buffalo New York, , United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00750698

Recruitment Status:

Terminated

Sponsor:


Syndax Pharmaceuticals

How clear is this clinincal trial information?

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