Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title: A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy

Status Terminated

Clinical Trial Summary

The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.

Clinical Trial Description

This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated.

In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone.

In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

• NCT number: NCT01741155
• Study type: Interventional
• Source: Spectrum Pharmaceuticals, Inc
• Status: Terminated
• Phase: Phase 2
• Start date: May 2013
• Completion date: July 2015