Carcinoma, Non-Small Cell Lung Clinical Trial
| NCT number | NCT00243204 |
| Other study ID # | PTH-304 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | October 19, 2005 |
| Last updated | June 7, 2007 |
| Start date | January 2006 |
| Verified date | June 2007 |
| Source | Point Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 400 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
INCLUSION CRITERIA: - 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 - ECOG Performance Status of 0 or 1 - Expected survival =12 weeks - Provide written informed consent EXCLUSION CRITERIA: - 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 - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cancer Care Institute of Carolina | Aiken | South Carolina |
| United States | New York Oncology Hematology, PC | Albany | New York |
| United States | Veena Charu, MD | Anaheim | California |
| United States | Alaska Cancer Research | Anchorage | Alaska |
| United States | Texas Cancer Center | Arlington | Texas |
| United States | Texas Oncology Cancer Center | Austin | Texas |
| United States | Medical Oncology, LLC | Baton Rouge | Louisiana |
| United States | Billings Clinic | Billings | Montana |
| United States | Pasco Hernando Oncology Associates PA | Brooksville | Florida |
| United States | Josephine Ford Cancer Center -- Downriver | Brownstown | Michigan |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Charleston Hematology Oncology, PA | Charleston | South Carolina |
| United States | The Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey |
| United States | Hematology Oncology Associates of Illinois | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | Oncology/Hematology Care, Inc. | Cincinnati | Ohio |
| United States | Michael McKenzie, DO | Clinton Township | Michigan |
| United States | Maryland Oncology Hematology, PA | Columbia | Maryland |
| United States | Mary Crowley Medical Research Center | Dallas | Texas |
| United States | Texas Cancer Center (Dallas Southwest) | Dallas | Texas |
| United States | Henry Ford Medical Center -- Fairlane | Dearborn | Michigan |
| United States | Texas Cancer Center / Denton | Denton | Texas |
| United States | Mile High Oncology | Denver | Colorado |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Gabrail Cancer Center | Dover | Ohio |
| United States | El Paso Cancer Treatment Center | El Paso | Texas |
| United States | Annandale-Fairfax Virginia Hematology Oncology, PC | Fairfax | Virginia |
| United States | Medical Specialists of Fairfield | Fairfield | Connecticut |
| United States | Lalita Pandit, MD, Inc | Fountain Valley | California |
| United States | Robert A. Moss, MD, FACP, Inc. | Fountain Valley | California |
| United States | Texas Oncology, PA | Ft. Worth | Texas |
| United States | US Oncology Research and Clinical Pharmacy | Ft. Worth | Texas |
| United States | Lucio Gordan, MD | Gainesville | Florida |
| United States | Shatish A. Shah, MD | Gettysburg | Pennsylvania |
| United States | Chesapeake Oncology Hematology Associates (Tate Center) | Glen Burnie | Maryland |
| United States | George A. Zervos, MD | Glen Head | New York |
| United States | Peninsula Cancer Institute | Gloucester | Virginia |
| United States | Kentucky Cancer Clinic | Hazard | Kentucky |
| United States | Northwestern Carolina Oncology Hematology | Hickory | North Carolina |
| United States | Marshall Schreeder, MD | Huntsville | Alabama |
| United States | Indiana Hematology Oncology Consultants | Indianapolis | Indiana |
| United States | Citrus Hematology and Oncology Center | Inverness | Florida |
| United States | Nature Coast Clinical Research, LLC | Inverness | Florida |
| United States | Joliet Oncology Hematology Associates | Joliet | Illinois |
| United States | Dayton Hematology and Oncology | Kettering | Ohio |
| United States | Medical Oncology Associates of Wyoming Valley, PC | Kingston | Pennsylvania |
| United States | Jorge G. Otoya, MD | Kissimmee | Florida |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Cancer and Blood Disease Center | Lecanto | Florida |
| United States | Mukesh C. Bhatt, MD | Medina | Ohio |
| United States | Texas Cancer Center of Mesquite | Mesquite | Texas |
| United States | Allison Cancer Center | Midland | Texas |
| United States | James P. Daugherty, MD | Muscle Shoals | Alabama |
| United States | Pasco Hernando Oncology Associates, PA | New Port Richey | Florida |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Ocala Oncology Center | Ocala | Florida |
| United States | Warren Paroly, MD | Oceanside | California |
| United States | Cancer Center of Florida | Ocoee | Florida |
| United States | West Texas Cancer Center | Odessa | Texas |
| United States | Cancer Care Associates | Oklahoma City | Oklahoma |
| United States | Kansas City Cancer Centers, Southwest | Overland Park | Kansas |
| United States | Paris Regional Cancer Center | Paris | Texas |
| United States | Rittenhouse Hematology Oncology Associates | Philadelphia | Pennsylvania |
| United States | Hematology Oncology Associates | Phoenix | Arizona |
| United States | Swarna S. Chanduri, MD | Pomona | California |
| United States | Youssef Hanna, MD | Port Huron | Michigan |
| United States | Northwest Cancer Specialists, Northrup | Portland | Oregon |
| United States | Southwest Cancer Care Medical Group | Poway | California |
| United States | Cancer and Transplant Consultants, PLC | Rochester Hills | Michigan |
| United States | Cancer Care Associates | Rochester Hills | Michigan |
| United States | Cancer Care Associates, PC | Royal Oak | Michigan |
| United States | Hematology Oncology Consultants | Royal Oak | Michigan |
| United States | Jeffrey H. Margolis, MD | Royal Oak | Michigan |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | Oncology & Hematology Associates of Southwest Virginia, Inc. | Salem | Virginia |
| United States | Puget Sound Cancer Centers | Seattle | Washington |
| United States | Northern Indiana Oncology Associates | South Bend | Indiana |
| United States | Michigan Hematology and Oncology Institute | Southgate | Michigan |
| United States | Palmetto Hematology Oncology, PC | Spartanburg | South Carolina |
| United States | Cancer Care Northwest Research | Spokane | Washington |
| United States | Jay L. Wittenkeller, MD | Spokane | Washington |
| United States | Oncology Care Associates, PLLC | St. Joseph | Michigan |
| United States | St. Joseph Oncology, Inc. | St. Joseph | Missouri |
| United States | Arch Medical Services, Inc. | St. Louis | Missouri |
| United States | Texas Oncology Cancer Center--Sugar Land | Sugar Land | Texas |
| United States | Mitchell Folbe, MD, PC | Troy | Michigan |
| United States | William Beaumont Hospital | Troy | Michigan |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| United States | Northwest Cancer Specialists, PC | Vancouver | Washington |
| United States | Henry Ford Medical Center | West Bloomfield | Michigan |
| United States | Chester County Hematology / Oncology Services | West Chester | Pennsylvania |
| United States | Peninsula Cancer Institute | Williamsburg | Virginia |
| United States | Masoom Kandahari, MD, PC | Woodbridge | Virginia |
| United States | Trilogy Cancer Center | Wooster | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Point Therapeutics |
United States,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04486833 -
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
|
Phase 1/Phase 2 | |
| Terminated |
NCT00321308 -
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00190840 -
A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT01441128 -
-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05358249 -
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
|
Phase 1/Phase 2 | |
| Terminated |
NCT02961283 -
Study of ASN003 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00973310 -
Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00385996 -
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT02775006 -
Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma
|
Phase 3 | |
| Completed |
NCT03232593 -
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
|
||
| Terminated |
NCT02590003 -
Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT01514864 -
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
|
Phase 2 | |
| Completed |
NCT00070629 -
CPG 7909 Injection in Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT02079636 -
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)
|
Phase 1 | |
| Completed |
NCT01079520 -
Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)
|
N/A | |
| Terminated |
NCT01115803 -
A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
|
Phase 1 | |
| Completed |
NCT00861627 -
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin for Non-Small Cell Lung Cancer With KRAS or EGFR Activation
|
Phase 2 | |
| Completed |
NCT00923884 -
Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer
|
||
| Recruiting |
NCT04389632 -
A Study of SGN-B6A in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT03603652 -
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
|
N/A |