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

NCT00750698 | Terminated Phase 2 Results

• 1 other identifier: SNDX-275-0403
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancer; non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

  At least 3 months

Secondary Outcomes (1)

• Progression-free Survival Rate

  Up to 4 months

Study Arms (2)

Erlotinib-responsive

EXPERIMENTAL

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.

Drug: Entinostat; Drug: Erlotinib

Erlotinib-nonresponsive

EXPERIMENTAL

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.

Drug: Entinostat; Drug: Erlotinib

Interventions

Entinostat DRUG

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

Also known as: SNDX-275

Erlotinib-nonresponsive; Erlotinib-responsive

Erlotinib DRUG

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

Also known as: Tarceva

Erlotinib-nonresponsive; Erlotinib-responsive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead

Study Sites (5)

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

entinostat; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Syndax Pharmaceuticals
• Organization: Syndax Pharmaceuticals

clinicaltrials@syndax.com

781-419-1400

Study Officials

• Alex Adjei, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-07

Locations

US (5)