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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Samir Witta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Cancer Centers

Authority:

United States: Food and Drug Administration

Study ID:

SNDX-275-0401

NCT ID:

NCT00602030

Start Date:

December 2007

Completion Date:

March 2012

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung
  • lung cancer
  • NSCLC
  • lung neoplasms
  • respiratory
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Rocky Mountain Cancer CenterDenver, Colorado  80218
Ocala Oncology CenterOcala, Florida  34474
Cancer Care NorthwestSpokane, Washington  99202
Cancer Centers of FloridaOrlando, Florida  32806
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Texas OncologyDallas, Texas  
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Highline Medical OncologyBurien, Washington  98166
Dayton Oncology & HematologyKettering, Ohio  45409
Kansas City Cancer CentersLenexa, Kansas  
The Center for Cancer Care & ResearchSt. Louis, Missouri  63141
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Advanced Medical SpecialtiesMiami, Florida  33176
HOPE (Hematology Oncology Physicians & Extenders)Tucson, Arizona  
Alliance Hematology OncologyWestminster, Maryland  
St Joseph OncologySt. Joseph, Missouri  
Mahonig Valley Hematology Oncology AssociatesBoardman, Ohio  
Oncololgy Associates of OregonEugene, Oregon  
Texas Oncology, Sammons Cancer CenterDallas, Texas  
Fairfax Northern Virginia Hematology-OncologyFairfax, Virginia  
Virgina Oncology AssociatesNorfolk, Virginia