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Spots Global Cancer Trial Database for Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

Official Title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy

Study ID: NCT00701870

Study Description

Brief Summary: TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

Detailed Description: TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel. After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Central Hematology Oncology Medical Group, Alhambra, California, United States

Pacific Cancer Medical Center, Inc., Anaheim, California, United States

Providence St. Joseph Medical Center, Burbank, California, United States

St. Jude Heritage Healthcare, Fullerton, California, United States

Wilshire Oncology Medical Group, La Verne, California, United States

UCLA Medical Center, Los Angeles, California, United States

Clinical Trials and Research Associates, Inc., Montebello, California, United States

North Valley Hematology/Oncology Medical Group, Northridge, California, United States

Ventura County Hematology-Oncology Specialists, Oxnard, California, United States

Samsum Clinic, Santa Barbara, California, United States

Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States

Central Coast Medical Oncology Corporation, Santa Maria, California, United States

Broward Oncology Associates, Ft. Lauderdale, Florida, United States

Nature Coast Clinical Research, Inverness, Florida, United States

Lakeland Regional Cancer Center, Lakeland, Florida, United States

Florida Hospital Cancer Institute, Ormand Beach, Florida, United States

Suburban Hematology-Oncology Associates, PC, Lawrenceville, Georgia, United States

Medical & Surgical Specialists, Galesburg, Illinois, United States

Joliet Oncology/Hematology Associates, Ltd., Joliet, Illinois, United States

Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States

Montefiore Medical Center, Bronx, New York, United States

Case Medical Center-University Hospitals, Cleveland, Ohio, United States

The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Coastal Cancer Center, Myrtle Beach, South Carolina, United States

Contact Details

Name: Gail Brown, MD

Affiliation: Telik

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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