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Study to Evaluate Erlotinib With or Without SNDX-275 in the Treatment of Patients With Advanced NSCLC

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ClinicalTrials.gov Identifier: NCT00602030
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE January 28, 2008
Last Update Posted Date April 19, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Progression-free survival rate [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00602030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
  • Progressive-free survival rate [ Time Frame: 6 months ]
  • Evaluate safety and tolerability of SNDX-275 in combination with erlotinib [ Time Frame: from date of randomization to discontinuation due to disease progression or intolerable AE ]
  • Evaluate pharmacokinetics of SNDX-275 in combination with erlotinib [ Time Frame: From randomization thru day 15 of Cycle 4 of study treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Progressive-free survival rate [ Time Frame: 6 months ]
  • Evaluate safety and tolerability of SNDX-275 in combination with erlotinib
  • Evaluate pharmacokinetics of SNDX-275 in combination with erlotinib
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Erlotinib With or Without SNDX-275 in the Treatment of Patients With Advanced NSCLC
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and efficacy of SNDX-275 in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small-Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: entinostat

    Dose cohort 1: SNDX-275 5mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)

    Dose cohort 2: SNDX-275 10mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)

  • Drug: SNDX-275
    entinostat 5mg or 10mg (determined by Lead in study findings) on days 1 and 15 of a 28-day cycle until progression or unacceptable toxicity develops; maximum of 6 cycles
  • Drug: erlotinib
    erlotinib 150mg PO QD
    Other Name: Tarceva
Study Arms  ICMJE
  • Experimental: 1
    Lead in Open Label Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation
    Interventions:
    • Drug: entinostat
    • Drug: erlotinib
  • Experimental: 2
    erlotinib (Tarceva) and entinostat
    Interventions:
    • Drug: SNDX-275
    • Drug: erlotinib
  • Placebo Comparator: 3

    erlotinib (Tarceva) and matched Placebo

    patients in this arm who progress will be offered the opportunity to receive SNDX-275 with erlotinib for up to 6 28-day treatment cycles

    Intervention: Drug: erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
132
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
107
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • 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 valporic acid) and progressed based on radiologic evidence
  • At least 1 measurable lesion by conventional or spiral CT scan
  • 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
  • Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L; ANC ≥ 1.5 x 109/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 /dL
  • AST and 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

Exclusion Criteria

  • Prior stem cell transplant
  • Clinical evidence of CNS involvement
  • Prior treatment with an HDAC inhibitor or an 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
  • Current use of valporic acid
  • Prior exposure to SNDX-275
  • 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 IV antibiotics, antivirals, or antifungals within 14 days before study drug administration
  • Known 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00602030
Other Study ID Numbers  ICMJE SNDX-275-0401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Syndax Pharmaceuticals
Study Sponsor  ICMJE Syndax Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir Witta, MD Rocky Mountain Cancer Centers
Principal Investigator: Kartik Konduri, MD Texas Oncology - Sammons Cancer Center
Principal Investigator: Robert Raju, MD Dayton Oncology
PRS Account Syndax Pharmaceuticals
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP