Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Entinostat

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Histone Deacetylase Inhibitors

Tyrosine

Participants self-administered entinostat in combination with continued erlotinib self-administration.

"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.

Participants self-administered entinostat in combination with continued erlotinib self-administration.

"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.

Entinostat (10 milligrams \[mg\] fixed dose orally \[PO\] every 2 weeks \[Q2W\]) on Days 1 and 15 of a 28-day cycle for up to 6 cycles

Erlotinib (150 mg PO QD) for up to six (6) 28-day cycles

Erlotinib

Alex Adjei, MD

To evaluate the tumor responses to SNDX-275 (entinostat) in combination with continued erlotinib in participants with non-small Cell Lung Carcinoma (NSCLC) who are progressing on erlotinib.

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

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

Syndax Pharmaceuticals

Erlotinib Responsive

Participants self-administered entinostat in combination with continued erlotinib self-administration.

"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.

Erlotinib Nonresponsive

Total

18 to <45

45 to <65

65 to <75

Age, Customized

Sex: Female, Male

All participants who received 1 dose of study drug.

Due to business reasons, enrollment on the study was halted and the study terminated.

Due to halted enrollment, data was not collected for analysis of this outcome measure.

Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months

Progression-free Survival Rate

Overall Study

Spots Global Cancer Trial Database for A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial