NCT01741155

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

November 27, 2012

Last Update Submit

October 8, 2021

Conditions

Non Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate(ORR) of SPI-1620

    To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC

    Up to 2 years

Secondary Outcomes (4)

  • Duration of Response (DoR)

    Up to 12 weeks

  • Progression-free survival(PFS)

    2 years from the start of study treatment

  • Overall survival (OS)

    2 years from the start of study treatment

  • Safety of SPI-1620

    Up to 2 years

Study Arms (3)

Single Arm Part: SPI-1620 & Docetaxel

EXPERIMENTAL

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.

Drug: SPI-1620Drug: Docetaxel

Randomized Part: SPI-1620 & Docetaxel

EXPERIMENTAL

Patients will receive 11 μg/m\^2 of SPI-1620 intravenous (IV) followed by docetaxel 75 mg/m\^2 IV administered in 3-week cycles until progression or intolerable toxicity.

Drug: SPI-1620Drug: Docetaxel

Randomized Part: Docetaxel

ACTIVE COMPARATOR

Patients will receive 75 mg/m\^2 docetaxel in 3-week cycles until progression or intolerable toxicity.

Drug: Docetaxel

Interventions

SPI-1620DRUG

SPI-1620 11 μg/m2 administered intravenously over one minute.

Randomized Part: SPI-1620 & DocetaxelSingle Arm Part: SPI-1620 & Docetaxel
DocetaxelDRUG

Docetaxel: 75 mg/m2 administered as IV infusion.

Also known as: Taxotere
Randomized Part: DocetaxelRandomized Part: SPI-1620 & DocetaxelSingle Arm Part: SPI-1620 & Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Oncology Hematology Care Inc.

Cincinnati, Ohio, 45242, United States

Location

Tennessee Oncology PLLC

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sovateltideDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations

US(5)