Non-Small-Cell Lung CarcinomaPhase 1/2NCT00602030
Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC
A Phase 1/2 study testing Entinostat and Erlotinib in people with Non-Small-Cell Lung Carcinoma and Carcinoma, Non-Small Cell Lung, run by Syndax Pharmaceuticals at 30 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung
- What is being tested?
- Entinostat and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 30 sitesUnited States
- Study dates
- 8 Jan 2008to 1 Feb 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histologically confirmed NSCLC of stage IIIb or IV
- Received at least 1 but no more than 2 prior chemotherapy or chemoradiotherapy regimens for advanced NSCLC (that did not include erlotinib and valproic acid) and progressed based on radiologic evidence
- At least 1 measurable lesion by conventional or spiral computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 and life expectancy of at least 6 months
- Paraffin-embedded tumor specimen available for correlative studies
- Male or female over 18 years of age
Show all 14Show fewer
- Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 10^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without the use of hematopoietic growth factors
- Bilirubin and creatinine less than 2 times the upper limit of normal for the institution
- Albumin ≥ 2.5 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal for the institution
- Prothrombin time less than 1.5 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 SNDX-275
- Patient or legally acceptable representative has granted written informed consent before any study-specific procedure (including special screening tests) are performed
Who cannot join
- Prior stem cell transplant
- Clinical evidence of central nervous system (CNS) involvement
- Prior treatment with an histone deacetylase (HDAC) inhibitor or an epidermal growth factor receptor (EGFR) inhibitor
- Currently taking known inhibitors of CYPA4, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, ≥ 10 mg prednisone, and voriconazole
- Currently taking medication(s) on the prohibited medication list
- Prior exposure to SNDX-275
Show all 18Show fewer
- Systemic chemotherapy, radiotherapy, or treatment with an investigational agent without recovery to at least grade 1 or baseline before study drug administration
- Daily treatment with ≥ 10 mg prednisone within 28 days before study drug administration
- Local or whole brain palliative radiotherapy within 14 days before 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, carcinoma in situ of the bladder, or papillary thyroid cancer
- Inability to swallow oral medications or a gastrointestinal malabsorption condition
- Acute infection requiring intravenous (IV) antibiotics, antivirals, or antifungals within 14 days before study drug administration
- Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection
- Another serious or uncontrolled medical condition within 90 days before study drug administration such as acute myocardial infarction, angina, ventricular arrhythmias, hypertension, diabetes mellitus, or renal or hepatic insufficiency
- Known hypersensitivity to benzamides
- Women who are currently pregnant or breast-feeding
- Patient currently is enrolled in (or completed within 28 days before study drug administration) another investigational drug study
- Patient has any kind of medical, psychiatric, or behavioral disorder that places the patient at increased risk for study participation or compromises the ability of the patient to give written informed consent and/or to comply with study procedures and requirements
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Texas Oncology
Amarillo, Texas
Texas Oncology
Austin, Texas
Texas Oncology
Bedford, Texas
Mahonig Valley Hematology Oncology Associates
Boardman, Ohio
Highline Medical Oncology
Burien, Washington
Hematology Oncology Associates of Illinois
Chicago, Illinois
Texas Oncology, Sammons Cancer Center
Dallas, Texas
Texas Oncology
Dallas, Texas
Rocky Mountain Cancer Center
Denver, Colorado
Oncology Associates of Oregon
Eugene, Oregon
Fairfax Northern Virginia Hematology-Oncology
Fairfax, Virginia
Texas Oncology
Fort Worth, Texas
Texas Oncology
Garland, Texas
Central Indiana Cancer Centers
Indianapolis, Indiana
Dayton Oncology & Hematology
Kettering, Ohio
Texas Oncology
Longview, Texas
Advanced Medical Specialties
Miami, Florida
Texas Oncology
Midland, Texas
Virginia Oncology Associates
Norfolk, Virginia
Ocala Oncology Center
Ocala, Florida
Cancer Centers of Florida
Ocoee, Florida
Texas Oncology
Odessa, Texas
Kansas City Cancer Centers
Overland Park, Kansas
St Joseph Oncology
Saint Joseph, Missouri
Cancer Care Northwest
Spokane, Washington
The Center for Cancer Care & Research
St Louis, Missouri
HOPE (Hematology Oncology Physicians & Extenders)
Tucson, Arizona
Texas Oncology
Tyler, Texas
Alliance Hematology Oncology
Westminster, Maryland
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With NSCLC After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).
- Being tested
- Entinostat, Placebo, Erlotinib
- Keywords
- lung cancer, NSCLC, lung neoplasms, respiratory
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntinostatDrug
Also called SNDX-275
Entinostat tablets on Days 1 and 15 of a 28-day cycle.
PlaceboDrug
Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.
ErlotinibDrug
Also called Tarceva
Erlotinib 150 mg tablets once daily.
| Study group | Role | What they receive |
|---|---|---|
| Lead-in Phase: Erlotinib + Entinostat 5 mg | Experimental | Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. Receives: Drug: Entinostat; Drug: Erlotinib |
| Lead-in Phase: Erlotinib + Entinostat 10 mg | Experimental | Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. Receives: Drug: Entinostat; Drug: Erlotinib |
| Double-blind Phase: Erlotinib + Entinostat 10 mg | Experimental | Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. Receives: Drug: Entinostat; Drug: Erlotinib |
| Double-blind Phase: Erlotinib + Placebo | Placebo comparator | Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. Receives: Drug: Placebo; Drug: Erlotinib |
| Crossover Phase: Erlotinib + Entinostat 10 mg | Experimental | Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities. Receives: Drug: Entinostat; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase
Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=life-threatening and 5=death. The dose that was found to be safe is reported.
Measured: Cycle 1 of Lead-in Phase
4-Month Progression-free Survival (PFS) Rate in the Double-blind Phase
PFS rate at 4 months was defined as the percentage of participants who are progression-free at 4 months.
Measured: Month 4
Secondary outcomes (14)
Objective Response Rate (ORR) in the Double-blind Phase
ORR was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions and normalization of tumor marker level. PR=At least a 30% decrease in the sum of the longest diameter of target lesions, taking at reference the baseline sum longest diameter.
Measured: Month 6
6-Month PFS Rate in the Double-blind Phase
PFS rate at 6 months is defined as the percentage of participants who are progression-free at 6 months.
Measured: Month 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. A TEAE is an AE that starts after the administration of study drug.
A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard.
TEAE severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Measured: First dose of study drug to within 30 days past last dose (Up to 7 months)
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Laboratory tests included tests of Hematology and Chemistry. The individual laboratory values were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Heart Rate in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Respiration Rate in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Temperature in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Weight in the Double-blind Phase
Measured: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase
Measured: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
Tmax: Time to Cmax of Entinostat in the Lead-in Phase
Measured: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase
Measured: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase
Measured: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study start8 Jan 2008
- Primary completion4 Feb 2010
- Study completion1 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir Witta, MD, Principal investigator, Rocky Mountain Cancer CentersKartik Konduri, MD, Principal investigator, Texas Oncology - Sammons Cancer CenterRobert Raju, MD, Principal investigator, Dayton Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602030
- Sponsor's protocol ID
- SNDX-275-0401
- Status last verified
- Aug 2022
- First submitted
- 25 Jan 2008
- Last updated
- 22 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With NSCLC After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease
- ClinicalTrials.gov ID
- NCT00602030
- Acronym / sponsor ID
- SNDX-275-0401
- Keywords
- lung cancer, NSCLC, lung neoplasms, respiratory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2008 (actual)
- Primary completion
- 4 Feb 2010 (actual)
- Study completion
- 1 Feb 2012 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lead-in Phase: Erlotinib + Entinostat 5 mg | Experimental | Drug: Entinostat, Drug: ErlotinibErlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. |
| Lead-in Phase: Erlotinib + Entinostat 10 mg | Experimental | Drug: Entinostat, Drug: ErlotinibErlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. |
| Double-blind Phase: Erlotinib + Entinostat 10 mg | Experimental | Drug: Entinostat, Drug: ErlotinibErlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. |
| Double-blind Phase: Erlotinib + Placebo | Placebo comparator | Drug: Placebo, Drug: ErlotinibErlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. |
| Crossover Phase: Erlotinib + Entinostat 10 mg | Experimental | Drug: Entinostat, Drug: ErlotinibParticipants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Cytologically or histologically confirmed NSCLC of stage IIIb or IV
- Received at least 1 but no more than 2 prior chemotherapy or chemoradiotherapy regimens for advanced NSCLC (that did not include erlotinib and valproic acid) and progressed based on radiologic evidence
- At least 1 measurable lesion by conventional or spiral computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 and life expectancy of at least 6 months
- Paraffin-embedded tumor specimen available for correlative studies
Key exclusion criteria (18 listed)
- Prior stem cell transplant
- Clinical evidence of central nervous system (CNS) involvement
- Prior treatment with an histone deacetylase (HDAC) inhibitor or an epidermal growth factor receptor (EGFR) inhibitor
- Currently taking known inhibitors of CYPA4, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, ≥ 10 mg prednisone, and voriconazole
- Currently taking medication(s) on the prohibited medication list
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntinostatAlso: SNDX-275Entinostat tablets on Days 1 and 15 of a 28-day cycle. | Drug | Crossover Phase: Erlotinib + Entinostat 10 mg, Double-blind Phase: Erlotinib + Entinostat 10 mg, Lead-in Phase: Erlotinib + Entinostat 10 mg, Lead-in Phase: Erlotinib + Entinostat 5 mg |
| PlaceboPlacebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle. | Drug | Double-blind Phase: Erlotinib + Placebo |
| ErlotinibAlso: TarcevaErlotinib 150 mg tablets once daily. | Drug | Crossover Phase: Erlotinib + Entinostat 10 mg, Double-blind Phase: Erlotinib + Entinostat 10 mg, Double-blind Phase: Erlotinib + Placebo, Lead-in Phase: Erlotinib + Entinostat 10 mg, Lead-in Phase: Erlotinib + Entinostat 5 mg |
Primary outcome
Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase
Time frame: Cycle 1 of Lead-in Phase
Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=life-threatening and 5=death. The dose that was found to be safe is reported.
4-Month Progression-free Survival (PFS) Rate in the Double-blind Phase
Time frame: Month 4
PFS rate at 4 months was defined as the percentage of participants who are progression-free at 4 months.
14 secondary outcomes
Objective Response Rate (ORR) in the Double-blind Phase
Time frame: Month 6
6-Month PFS Rate in the Double-blind Phase
Time frame: Month 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
Time frame: First dose of study drug to within 30 days past last dose (Up to 7 months)
Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Heart Rate in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Respiration Rate in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Temperature in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Vital Sign Values: Weight in the Double-blind Phase
Time frame: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)
Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase
Time frame: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
Tmax: Time to Cmax of Entinostat in the Lead-in Phase
Time frame: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase
Time frame: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase
Time frame: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Witta, MD principal investigator
Rocky Mountain Cancer Centers
Kartik Konduri, MD principal investigator
Texas Oncology - Sammons Cancer Center
Robert Raju, MD principal investigator
Dayton Oncology
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Entinostat and Erlotinib in people with Non-Small-Cell Lung Carcinoma and Carcinoma, Non-Small Cell Lung, run by Syndax Pharmaceuticals at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase (time frame: Cycle 1 of Lead-in Phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.