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

NCT ID: NCT00750698

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib-responsive

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.

Group Type: EXPERIMENTAL

Entinostat

Intervention Type: 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

Erlotinib

Intervention Type: DRUG

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

Erlotinib-nonresponsive

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.

Group Type: EXPERIMENTAL

Entinostat

Intervention Type: 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

Erlotinib

Intervention Type: DRUG

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

Interventions

Entinostat

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

Intervention Type: DRUG

Erlotinib

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

Intervention Type: DRUG

Other Intervention Names

SNDX-275; Tarceva

Eligibility Criteria

Inclusion Criteria

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 participant's screening into the study)

3. 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)

4. At least 1 measurable lesion ≥ 20 millimeters (mm) by conventional computed tomography (CT) scan or ≥ 10 mm by spiral CT scan

5. Eastern Cooperative Oncology Group 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 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

9. Coagulation tests within the normal range

10. Bilirubin and creatinine less than 2 times the upper limit of normal for the institution

11. Aspartate aminotransferase and alanine aminotransferase 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 entinostat

14. Participant or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) is performed

Exclusion Criteria

1. Prior stem cell transplant

2. Symptomatic central nervous system involvement

3. Prior treatment with an histone deacetylase 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 intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection

12. 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

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. Participant is currently enrolled in (or completed within 28 days) another investigational drug study

18. Participant unavailable for on-study or follow-up assessments

19. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syndax Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Adjei, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Sharp Clinical Oncology Research

San Diego, California, United States

University of Miami

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

SNDX-275-0403

Identifier Type: -

Identifier Source: org_study_id