Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neutropenia

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Docetaxel

Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery

Chemotherapy with docetaxel and carboplatin alone

4500 mg orally per day in two divided doses

ezatiostat hydrochloride (Telintra®)

Gail Brown, MD

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.

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.

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

Telik

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Enzyme Inhibitors

Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.

Gail L Brown, MD

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).

Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome

Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome

Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

Recording and grading of AEs using NCI-CTCAE v4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer	NCT00701870	Non-small Cell ...	ezatiostat hydr...	18 Years -	Telik
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer	NCT00701870	Non-small Cell ...	ezatiostat hydr...	18 Years -	Telik
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome	NCT01459159	Myelodysplastic...	ezatiostat hydr...	18 Years -	Telik

Spots Global Cancer Trial Database for ezatiostat hydrochloride (telintra®)