Non Small Cell Lung CancerPhase 2NCT00750698
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 study testing Entinostat and Erlotinib in people with Non Small Cell Lung Cancer, run by Syndax Pharmaceuticals at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Entinostat and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Jun 2010
- Phase
- Phase 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 (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
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- 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
Who cannot join
- 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
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- 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
- Women who are currently pregnant or breast-feeding
- Participant is currently enrolled in (or completed within 28 days) another investigational drug study
- Participant unavailable for on-study or follow-up assessments
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Cancer Institute
Buffalo, New York
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
University of Miami
Miami, Florida, 33136
Sharp Clinical Oncology Research
San Diego, California, 92123
About this 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
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
- Being tested
- Entinostat, Erlotinib
- Keywords
- lung cancer, non small cell lung cancer
- 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 (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
ErlotinibDrug
Also called Tarceva
Erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Entinostat; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months
Measured: At least 3 months
Secondary outcomes (1)
Progression-free Survival Rate
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionJun 2010
Why it stopped: Due to business reasons, enrollment on the study was halted and the study terminated. The decision to close enrollment was not due to any safety concern.
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 CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Adjei, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750698
- Sponsor's protocol ID
- SNDX-275-0403
- Status last verified
- Jul 2023
- First submitted
- 8 Sep 2008
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00750698
- Acronym / sponsor ID
- SNDX-275-0403
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, non small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to business reasons, enrollment on the study was halted and the study terminated. The decision to close enrollment was not due to any safety concern.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib-responsive | Experimental | Drug: Entinostat, Drug: ErlotinibParticipants 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. |
| Erlotinib-nonresponsive | Experimental | Drug: Entinostat, Drug: ErlotinibParticipants 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. |
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 (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
Key exclusion criteria (19 listed)
- 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
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 (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 | Drug | Erlotinib-nonresponsive, Erlotinib-responsive |
| ErlotinibAlso: TarcevaErlotinib (150 mg PO QD) for up to six (6) 28-day cycles | Drug | Erlotinib-nonresponsive, Erlotinib-responsive |
Primary outcome
Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months
Time frame: At least 3 months
1 secondary outcome
Progression-free Survival Rate
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
Alex Adjei, MD study chair
Roswell Park Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entinostat and Erlotinib in people with Non Small Cell Lung Cancer, run by Syndax Pharmaceuticals at 5 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 19 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: stopped early, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 6 Jul 2023). 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?
Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months (time frame: At least 3 months). 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 6 Jul 2023.