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A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy


Inclusion Criteria:



- Men or women age ≥18 years

- Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or
metastatic, inoperable NSCLC [Stage IIIB/IV]. Patients with Stage IIIB NSCLC must
have a cytologically documented pleural effusion.)

- Failed or relapsed after receiving a platinum-containing chemotherapy regimen as
first-line therapy for advanced NSCLC

- Measurable disease on computerized tomography (CT) scan

- ECOG Performance Status of 0 or 1

- Expected survival ≥12 weeks

- Provide written informed consent

Exclusion Criteria:

- More than 2 prior chemotherapy regimens

- Progression of disease on prior pemetrexed treatment

- Brain metastases (exception: patients who had a resection and/or completed a course
of cranial irradiation, have no worsening CNS symptoms, and have discontinued all
corticosteroids for that indication for at least 1 month)

- Serum creatinine ≥2.0mg/dL or creatinine clearance <45mL/min

- Absolute neutrophil count <1500/μL or platelets <100,000/μL

- Any malignancy within 5 years immediately prior to the first dose of study medication
(exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and
carcinoma in-situ of the cervix)

- Any comorbidity or condition which, in the opinion of the investigator, may interfere
with the assessments and procedures of this protocol

- Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or
investigational medication for NSCLC. Patients must have recovered from all of the
side effects of treatment.

- Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must
agree to use a barrier method of contraception during treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

PTH-305

NCT ID:

NCT00290017

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Neoplasms, Lung
  • Neoplasms, Pulmonary
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
William Beaumont HospitalRoyal Oak, Michigan  48073
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Oncology/Hematology Care, Inc.Cincinnati, Ohio  45219
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Cancer Care AssociatesTulsa, Oklahoma  74136
Cascade Cancer CenterKirkland, Washington  98034-3013
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Associates in Oncology and HematologyChattanooga, Tennessee  37404
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Northwestern Connecticut Oncology Hematology Associates, LLPTorrington, Connecticut  06790
Texas Oncology, PADallas, Texas  75246-2006
Mercy Medical CenterBaltimore, Maryland  21202
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
West Texas Cancer CenterOdessa, Texas  79761
Kentucky Cancer ClinicPikeville, Kentucky  41501
Mile High OncologyDenver, Colorado  80210
Medical Consultants, Ltd.Milwaukee, Wisconsin  53215
Hematology Oncology AssociatesPhoenix, Arizona  85012
Cancer Center of FloridaOcoee, Florida  34761
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
Cancer Care Institute of CarolinaAiken, South Carolina  29801
VA Sierra Nevada Health Care SystemReno, Nevada  89502
Oncology & Hematology Associates of Southwest VirginiaRoanoke, Virginia  24101
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
New York Oncology Hematology, PCAlbany, New York  12208
Puget Sound Cancer CentersEdmonds, Washington  98026
Northwest Cancer Specialists, PCVancouver, Washington  98684
Northern Indiana Oncology AssociatesSouth Bend, Indiana  46617
Paris Regional Cancer CenterParis, Texas  75460
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Antelope Valley Cancer CenterLancaster, California  93534
Northwestern Carolina Oncology & Hematology, PAHickory, North Carolina  28602
Cancer and Blood Disease CenterLecanto, Florida  34461
McLeod Cancer and Blood CenterJohnson City, Tennessee  37604
Dayton Oncology & Hematology, PAKettering, Ohio  45409
Medical Specialists of FairfieldFairfield, Connecticut  
University of TennesseeMemphis, Tennessee  38163
Marshall Schreeder, MDHuntsville, Alabama  35801
Robert A. Moss, MD, FACP, Inc.Fountain Valley, California  92708
Warren Paroly, MDOceanside, California  92056
Southwest Cancer Care Medical GroupPoway, California  92064-2527
Lucio Gordan, MDGainesville, Florida  32605
Chesapeake Oncology Hematology Associates (Tate Center)Glen Burnie, Maryland  21061
Michael McKenzie, DOClinton Township, Michigan  48038
Youssef Hanna, MDPort Huron, Michigan  48060
Cancer and Transplant Consultants, PLCRochester Hills, Michigan  48307
Cancer Care AssociatesRochester Hills, Michigan  48307
Cancer Care Associates, PCRoyal Oak, Michigan  48073
Hematology Oncology ConsultantsRoyal Oak, Michigan  48073
Jeffrey H. Margolis, MDRoyal Oak, Michigan  48073
Rittenhouse Hematology Oncology AssociatesPhiladelphia, Pennsylvania  19146
Texas Cancer Center (Dallas Southwest)Dallas, Texas  75237
Texas Cancer Center / DentonDenton, Texas  76210
US Oncology Research and Clinical PharmacyFt. Worth, Texas  76177
Texas Oncology Cancer Center--Sugar LandSugar Land, Texas  77479
Heritage Physician Group—OncologyHot Springs, Arkansas  71913
Raul R. Mena, MDBurbank, California  91505-4866
Pacific Coast Hematology / Oncology Medical Group, Inc.Fountain Valley, California  92708
Joliet Oncology-Hematology AssociatesJoliet, Illinois  60435
American Health Network of Indiana--Hematology/OncologyIndianapolis, Indiana  46202
Arnett Cancer CenterLafayette, Indiana  08822
Associated Physicians and Surgeons, LLCTerre Haute, Indiana  47804-4080
HUX Cancer Center/Union HospitalTerre Haute, Indiana  47804-4080
Kansas City Cancer Center, LLCOverland Park, Kansas  66210
Carroll County Cancer CenterWestminster, Maryland  21157
Fallon Clinic, Inc. at Worcester Medical CenterWorcester, Massachusetts  01608
Dr. Folbe, MD/PCTroy, Michigan  48085
Hematology Oncology Associates, SJ, PAMount Holly, New Jersey  08060
Mercer Bucks Oncology/HematologyTrenton, New Jersey  08618
Capital Health SystemTrenton, New Jersey  08618
Eugene Paschold, MDWinston Salem, North Carolina  27013
Piedmont Hematology Oncology / Winston-SalemWinston-Salem, North Carolina  27103
Satish A. Shah, MDGettysburg, Pennsylvania  17325
St. Mary Medical Center--Research CenterLanghorne, Pennsylvania  19047
Hematology-Oncology Group, PCLanghorne, Pennsylvania  19047
Paoli HospitalPaoli, Pennsylvania  19301
Grandview HospitalSellersville, Pennsylvania  
Bux-Mont Oncology-HematologySellersville, Pennsylvania  18960
Palmetto Hematology Oncology PCSpartanburg, South Carolina  29303-3041
El Paso Cancer Treatment Center--EastEl Paso, Texas  79915
Texas Oncology, PA / Allison Cancer CenterMidland, Texas  79701-5946
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLCAbingdon, Virginia  24211
Fairfax Northern Virginia Hematology / Oncology, PCFairfax, Virginia  22031
Virginia Physicians, Inc.Richmond, Virginia  23229
Luke Walker, MDEverett, Washington  98206