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TerminatedPhase 2NCT01741155
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSPI-1620 and Docetaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 13, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Spectrum Pharmaceuticals, Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Spectrum Pharmaceuticals, Inc
Interventions being studied
Drug: SPI-1620; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Oncology Hematology Care Inc.Cincinnati, Ohio
  • Tennessee Oncology PLLCChattanooga, Tennessee
  • Tennessee OncologyNashville, Tennessee
  • The Center for Cancer and Blood DisordersFort Worth, Texas
  • Virginia Cancer InstituteRichmond, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2021. Always confirm current availability with the study team.

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