Study Stopped
Study TLK199.2102 was terminated for lack of enrollment.
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
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
1 other identifier
interventional
1
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Oct 2008
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 27, 2013
November 1, 2013
1 month
June 18, 2008
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of chemotherapy induced neutropenia
6 weeks
Secondary Outcomes (6)
Duration of chemotherapy induced severe neutropenia
6 weeks
Time to ANC recovery from ANC nadir
6 weeks
Incidence of febrile neutropenia
6 weeks
Incidence of G-CSF administration
6 weeks
FACT-N quality of life assessment
6 weeks
- +1 more secondary outcomes
Study Arms (2)
ezatiostat hydrochloride (Telintra®)
EXPERIMENTALChemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
No Intervention
NO INTERVENTIONChemotherapy with docetaxel and carboplatin alone
Interventions
4500 mg orally per day in two divided doses
Eligibility Criteria
You may qualify if:
- Histologically confirmed NSCLC
- Stage IIIb-Stage IV NSCLC
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate bone marrow reserve
You may not qualify if:
- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- Histologically confirmed mixed tumors containing small cell elements
- Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- History of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
- History of HIV
- Grade 3 or 4 peripheral neuropathy
- Weightloss greater than 5% within 6 months
- Uncontrolled pleural effusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (24)
Central Hematology Oncology Medical Group
Alhambra, California, 91801, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Samsum Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Ormand Beach, Florida, 32174, United States
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, 30045, United States
Medical & Surgical Specialists
Galesburg, Illinois, 61401, United States
Joliet Oncology/Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Case Medical Center-University Hospitals
Cleveland, Ohio, 44106, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Coastal Cancer Center
Myrtle Beach, South Carolina, 29572-4128, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gail Brown, MD
Telik
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
November 27, 2013
Record last verified: 2013-11