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Carcinoma, Non-Small Cell LungPhase 3NCT00243204

Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

A Phase 3 study testing talabostat mesylate and docetaxel in people with Carcinoma, Non-Small Cell Lung, run by Point Therapeutics at 96 sites in United States.

Terminated

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

Official record
Search all trials

Trial summary

This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel 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
Conditions the study is for
Carcinoma, Non-Small Cell Lung
What is being tested?
talabostat mesylate and docetaxel
How many people
400 participants
Where
96 sitesUnited States
Study dates
Jan 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 or older
  • 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
Show all 9Show fewer
  • ECOG Performance Status of 0 or 1
  • Expected survival ≥12 weeks
  • Provide written informed consent

Who cannot join

  • More than 2 prior chemotherapy regimens
  • Clinically significant laboratory abnormalities, specifically:
  • Total bilirubin ≥ institutional upper limit of normal (ULN)
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
  • Serum creatinine ≥2.0mg/dL
  • Absolute neutrophil count <1500/μL or platelets <100,000/μL
Show all 12Show fewer
  • Untreated or symptomatic brain metastases
  • Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
  • A history of severe hypersensitivity to drugs formulated with polysorbate 80
  • 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 other investigational medication for NSCLC.
  • Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Cancer Care Institute of Carolina

    Aiken, South Carolina, 29801

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Veena Charu, MD

    Anaheim, California, 92801

  • Alaska Cancer Research

    Anchorage, Alaska, 99508

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Medical Oncology, LLC

    Baton Rouge, Louisiana, 70809

  • Billings Clinic

    Billings, Montana, 59101

  • Pasco Hernando Oncology Associates PA

    Brooksville, Florida, 34613

  • Josephine Ford Cancer Center -- Downriver

    Brownstown, Michigan, 48183

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology, PA

    Charleston, South Carolina, 29403

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Michael McKenzie, DO

    Clinton Township, Michigan, 48038

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Texas Cancer Center (Dallas Southwest)

    Dallas, Texas, 75237

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Henry Ford Medical Center -- Fairlane

    Dearborn, Michigan, 48126

  • Texas Cancer Center / Denton

    Denton, Texas, 76210

  • Mile High Oncology

    Denver, Colorado, 80210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Gabrail Cancer Center

    Dover, Ohio, 44622

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79915

  • Annandale-Fairfax Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Medical Specialists of Fairfield

    Fairfield, Connecticut, 06824

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • US Oncology Research and Clinical Pharmacy

    Fort Worth, Texas, 76177

  • Lalita Pandit, MD, Inc

    Fountain Valley, California, 92708

  • Robert A. Moss, MD, FACP, Inc.

    Fountain Valley, California, 92708

  • Lucio Gordan, MD

    Gainesville, Florida, 32605

  • Shatish A. Shah, MD

    Gettysburg, Pennsylvania, 17325

  • Chesapeake Oncology Hematology Associates (Tate Center)

    Glen Burnie, Maryland, 21061

  • George A. Zervos, MD

    Glen Head, New York, 11545

  • Peninsula Cancer Institute

    Gloucester, Virginia, 23061

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Northwestern Carolina Oncology Hematology

    Hickory, North Carolina, 28602

  • Marshall Schreeder, MD

    Huntsville, Alabama, 35801

  • Indiana Hematology Oncology Consultants

    Indianapolis, Indiana, 46202

  • Citrus Hematology and Oncology Center

    Inverness, Florida, 34452

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Joliet Oncology Hematology Associates

    Joliet, Illinois, 60435

  • Dayton Hematology and Oncology

    Kettering, Ohio, 45409

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Jorge G. Otoya, MD

    Kissimmee, Florida, 34741

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Cancer and Blood Disease Center

    Lecanto, Florida, 34461

  • Mukesh C. Bhatt, MD

    Medina, Ohio, 44256

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701-5946

  • James P. Daugherty, MD

    Muscle Shoals, Alabama, 35661

  • Pasco Hernando Oncology Associates, PA

    New Port Richey, Florida, 34652

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • 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, 73112

  • Kansas City Cancer Centers, Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460-5004

  • Rittenhouse Hematology Oncology Associates

    Philadelphia, Pennsylvania, 19146

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Swarna S. Chanduri, MD

    Pomona, California, 91767

  • Youssef Hanna, MD

    Port Huron, Michigan, 48060

  • Northwest Cancer Specialists, Northrup

    Portland, Oregon, 97210

  • Southwest Cancer Care Medical Group

    Poway, California, 92064-2527

  • 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

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Centers

    Seattle, Washington, 98133

  • Northern Indiana Oncology Associates

    South Bend, Indiana, 46617

  • Michigan Hematology and Oncology Institute

    Southgate, Michigan, 48195

  • Palmetto Hematology Oncology, PC

    Spartanburg, South Carolina, 29303-3041

  • Jay L. Wittenkeller, MD

    Spokane, Washington, 99204

  • Cancer Care Northwest Research

    Spokane, Washington, 99218

  • Arch Medical Services, Inc.

    St Louis, Missouri, 63141

  • Texas Oncology Cancer Center--Sugar Land

    Sugar Land, Texas, 77479

  • Mitchell Folbe, MD, PC

    Troy, Michigan, 48085

  • William Beaumont Hospital

    Troy, Michigan, 48085

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Henry Ford Medical Center

    West Bloomfield, Michigan, 48322

  • Chester County Hematology / Oncology Services

    West Chester, Pennsylvania, 19380

  • Peninsula Cancer Institute

    Williamsburg, Virginia, 23185

  • Masoom Kandahari, MD, PC

    Woodbridge, Virginia, 22191

  • Trilogy Cancer Center

    Wooster, Ohio, 44691

Other trials in United States

About this study

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

Being tested
talabostat mesylate, docetaxel
Keywords
Stage IIIb/IV non-small cell lung cancer, NSCLC, 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.

Timeline

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

  1. First posted21 Oct 2005 (estimated)
  2. Study startJan 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
Parallel groups
Masking
Double blind
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00243204
Sponsor's protocol ID
PTH-304
Status last verified
Jun 2007
First submitted
19 Oct 2005
Last updated
8 Jun 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing talabostat mesylate and docetaxel in people with Carcinoma, Non-Small Cell Lung, run by Point Therapeutics at 96 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 9 inclusion and 12 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 96 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 NCT00243204.

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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