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Carcinoma, Non-Small-Cell LungPhase 3NCT00290017

Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

A Phase 3 study testing talabostat and pemetrexed in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by Point Therapeutics at 101 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
talabostat and pemetrexed
How many people
400 participants
Where
101 sitesUnited States
Study dates
Feb 2006to not given
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

101 sites in 1 country.

101 sites in 1 country

United States101 sites

  • Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC

    Abingdon, Virginia, 24211

  • Cancer Care Institute of Carolina

    Aiken, South Carolina, 29801

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Raul R. Mena, MD

    Burbank, California, 91505-4866

  • Minnesota Oncology Hematology, PA

    Burnsville, Minnesota, 55337

  • Charleston Hematology Oncology, PA

    Charleston, South Carolina, 29403

  • Associates in Oncology and Hematology

    Chattanooga, Tennessee, 37404

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Michael McKenzie, DO

    Clinton Township, Michigan, 48038

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Texas Cancer Center (Dallas Southwest)

    Dallas, Texas, 75237

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Texas Cancer Center / Denton

    Denton, Texas, 76210

  • Mile High Oncology

    Denver, Colorado, 80210

  • El Paso Cancer Treatment Center--East

    El Paso, Texas, 79915

  • Texas Oncology, PA

    El Paso, Texas, 79915

  • Luke Walker, MD

    Everett, Washington, 98206

  • Fairfax Northern Virginia Hematology / Oncology, PC

    Fairfax, Virginia, 22031

  • Medical Specialists of Fairfield

    Fairfield, Connecticut, 06824

  • Hunterdon Regional Cancer Center

    Flemington, New Jersey, 08822

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • US Oncology Research and Clinical Pharmacy

    Fort Worth, Texas, 76177

  • Pacific Coast Hematology / Oncology Medical Group, Inc.

    Fountain Valley, California, 92708

  • Robert A. Moss, MD, FACP, Inc.

    Fountain Valley, California, 92708

  • Lucio Gordan, MD

    Gainesville, Florida, 32605

  • Satish A. Shah, MD

    Gettysburg, Pennsylvania, 17325

  • Chesapeake Oncology Hematology Associates (Tate Center)

    Glen Burnie, Maryland, 21061

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Northwestern Carolina Oncology & Hematology, PA

    Hickory, North Carolina, 28602

  • Heritage Physician Group-Oncology

    Hot Springs, Arkansas, 71913

  • Marshall Schreeder, MD

    Huntsville, Alabama, 35801

  • American Health Network of Indiana--Hematology/Oncology

    Indianapolis, Indiana, 46202

  • McLeod Cancer and Blood Center

    Johnson City, Tennessee, 37604

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois, 60435

  • Dayton Oncology & Hematology, PA

    Kettering, Ohio, 45409

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Cascade Cancer Center

    Kirkland, Washington, 98034-3013

  • University of Tennessee

    Knoxville, Tennessee, 37920

  • Arnett Cancer Center

    Lafayette, Indiana, 08822

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • Hematology-Oncology Group, PC

    Langhorne, Pennsylvania, 19047

  • St. Mary Medical Center--Research Center

    Langhorne, Pennsylvania, 19047

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Cancer and Blood Disease Center

    Lecanto, Florida, 34461

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Texas Oncology, PA

    Mesquite, Texas, 75150

  • Texas Oncology, PA / Allison Cancer Center

    Midland, Texas, 79701-5946

  • Medical Consultants, Ltd.

    Milwaukee, Wisconsin, 53215

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Hematology Oncology Associates, SJ, PA

    Mount Holly, New Jersey, 08060

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Warren Paroly, MD

    Oceanside, California, 92056

  • Cancer Center of Florida

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • Kansas City Cancer Center, LLC

    Overland Park, Kansas, 66210

  • Paoli Hospital

    Paoli, Pennsylvania, 19301

  • Paris Regional Cancer Center

    Paris, Texas, 75460-5004

  • Rittenhouse Hematology Oncology Associates

    Philadelphia, Pennsylvania, 19146

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Youssef Hanna, MD

    Port Huron, Michigan, 48060

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Southwest Cancer Care Medical Group

    Poway, California, 92064

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Virginia Physicians, Inc.

    Richmond, Virginia, 23229

  • Cancer and Transplant Consultants, PLC

    Rochester Hills, Michigan, 48307

  • Cancer Care Associates

    Rochester Hills, Michigan, 48307

  • Cancer Care Associates, PC

    Royal Oak, Michigan, 48073

  • Hematology Oncology Consultants

    Royal Oak, Michigan, 48073

  • Jeffrey H. Margolis, MD

    Royal Oak, Michigan, 48073

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Oncology & Hematology Associates of Southwest Virginia

    Salem, Virginia, 24153

  • Puget Sound Cancer Centers

    Seattle, Washington, 98133

  • Bux-Mont Oncology-Hematology

    Sellersville, Pennsylvania, 18960

  • Grandview Hospital

    Sellersville, Pennsylvania

  • Northern Indiana Oncology Associates

    South Bend, Indiana, 46617

  • Palmetto Hematology Oncology PC

    Spartanburg, South Carolina, 29303-3041

  • Cancer Care Northwest

    Spokane, Washington, 99218

  • Texas Oncology Cancer Center--Sugar Land

    Sugar Land, Texas, 77479

  • Associated Physicians and Surgeons, LLC

    Terre Haute, Indiana, 47804-4080

  • HUX Cancer Center/Union Hospital

    Terre Haute, Indiana, 47804-4080

  • Northwestern Connecticut Oncology Hematology Associates, LLP

    Torrington, Connecticut, 06790

  • Capital Health System

    Trenton, New Jersey, 08618

  • Mercer Bucks Oncology/Hematology

    Trenton, New Jersey, 08618

  • Dr. Folbe, MD/PC

    Troy, Michigan, 48085

  • William Beaumont Hospital

    Troy, Michigan, 48085

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Carroll County Cancer Center

    Westminster, Maryland, 21157

  • Eugene Paschold, MD

    Winston-Salem, North Carolina, 27013

  • Piedmont Hematology Oncology / Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Fallon Clinic, Inc. at Worcester Medical Center

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

Official title: 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

This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

Being tested
talabostat, pemetrexed
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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2006 (estimated)
  2. Study startFeb 2006

Why it stopped: FDA Hold May 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290017
Sponsor's protocol ID
PTH-305
Status last verified
Jun 2007
First submitted
9 Feb 2006
Last updated
8 Jun 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing talabostat and pemetrexed in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by Point Therapeutics at 101 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 7 inclusion and 9 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 8 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: FDA Hold May 2007). Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290017.

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 8 Jun 2007.

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