Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- Histologically confirmed NSCLC

- Stage IIIb-Stage IV NSCLC

- ECOG performance status of 0-2

- Adequate liver and renal function

- Adequate bone marrow reserve

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Duration of chemotherapy induced neutropenia

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Gail Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.2102

NCT ID:

NCT00701870

Start Date:

May 2008

Completion Date:

May 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Chemotherapy induced neutropenia
  • CIN
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neutropenia

Name

Location
Florida Hospital Cancer Institute Orlando, Florida  32804
Montefiore Medical Center Bronx, New York  10467-2490
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Joliet Oncology/Hematology Associates, Ltd. Joliet, Illinois  60435
Coastal Cancer Center Myrtle Beach, South Carolina  29572
UCLA Medical Center Los Angeles, California  90095-7059
Lakeland Regional Cancer Center Lakeland, Florida  33805
Broward Oncology Associates Ft. Lauderdale, Florida  33308
Providence St. Joseph Medical Center Burbank, California  91505
Wilshire Oncology Medical Group Glendora, California  91741
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Clinical Trials and Research Associates, Inc. Montebello, California  60460
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Suburban Hematology-Oncology Associates, Pc Lawrenceville, Georgia  30046
Medical & Surgical Specialists Galesburg, Illinois  61401
Pacific Cancer Medical Center, Inc. Anaheim, California  92801
Nature Coast Clinical Research Inverness, Florida  34452
SAMSUM Clinic Santa Barbara, California  93105
St. Jude Heritage Healthcare Fullerton, California  92835
Central Hematology Oncology Medical Group Alhambra, California  91801
Case Medical Center-University Hospitals Cleveland, Ohio  44106