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Sponsored by: |
Syndax Pharmaceuticals |
Information provided by: | Syndax Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00750698 |
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 | Intervention | Phase |
Non Small Cell Lung Cancer |
Drug: SNDX-275 Drug: erlotinib |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Erlotinib Erlotinib hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 70 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
"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.
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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
Drug: erlotinib
erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
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2: Experimental
"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.
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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
Drug: erlotinib
erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION:
EXCLUSION:
Contact: Jeannette Hasapidis | 781-419-1404 | jhasapidis@syndax.com |
Contact: Rachel Sorensen | 781-419-1410 | rsorensen@syndax.com |
United States, California | |||||
University of California San Diego | Not yet recruiting | ||||
La Jolla, California, United States | |||||
Sharp Memorial Hospital | Not yet recruiting | ||||
San Diego, California, United States | |||||
City of Hope | Not yet recruiting | ||||
Duarte, California, United States | |||||
United States, Florida | |||||
University of Miami, Miller School of Medicine | Recruiting | ||||
Miami, Florida, United States | |||||
United States, Georgia | |||||
Medical College of Georgia | Not yet recruiting | ||||
Augusta, Georgia, United States | |||||
United States, Illinois | |||||
RUSH University Medical Center | Not yet recruiting | ||||
Chicago, Illinois, United States | |||||
United States, Maryland | |||||
University of Maryland Medical Center | Not yet recruiting | ||||
Baltimore, Maryland, United States | |||||
United States, Minnesota | |||||
the Mayo Clinic | Not yet recruiting | ||||
Rochester, Minnesota, United States | |||||
United States, New York | |||||
Roswell Park Cancer Institute | Recruiting | ||||
Buffalo, New York, United States | |||||
United States, North Carolina | |||||
Blumenthal Cancer Center | Not yet recruiting | ||||
Charlotte, North Carolina, United States | |||||
United States, South Carolina | |||||
South Carolina Oncology Associates | Not yet recruiting | ||||
Columbia, South Carolina, United States | |||||
University of South Carolina | Recruiting | ||||
Charleston, South Carolina, United States |
Syndax Pharmaceuticals |
Study Chair: | Alex Adjei, MD | Roswell Park Cancer Institute |
Responsible Party: | Syndax Pharmaceuticals, Inc. ( Jeannette Hasapidis, Associate Director of Clinical Trials Management ) |
Study ID Numbers: | SNDX-275-0403 |
First Received: | September 8, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00750698 |
Health Authority: | United States: Food and Drug Administration |
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