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

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT01741155

Run by

Spectrum Pharmaceuticals, Inc

People needed

34

Starts

2013-05-01

Expected to finish

2015-07-01

Last updated by the study team

2021-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Oncology Hematology Care Inc. — Cincinnati, Ohio, United States
• Tennessee Oncology PLLC — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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