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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy

• Measurable disease as per RECIST v. 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• More than one prior chemotherapy regimen for metastatic NSCLC

• Known, uncontrolled central nervous system (CNS) metastases

• Significant circulatory disorders in the past 6 mo.

• Concomitant treatment with phosphodiesterase inhibitors

• Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)