Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer

Telik

Status and phase

Completed

Phase 2

Phase 1

Conditions

Carcinoma, Non-small-cell Lung

Treatments

Drug: TLK286 in combination with docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00047801

TLK286.2012

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include:

Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
Stage IV or Stage IIIB
Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
At least 18 years of age
Good performance status (ECOG 0 to 1)
Adequate liver, renal, and bone marrow function

Exclusion criteria include:

Pregnant or lactating women
Treatment with more than one cytotoxic therapy
Prior radiation to the whole pelvis
Unstable medical conditions such as uncontrolled cardiac arrhythmia
Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80