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

NCT ID: NCT01741155

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm Part: SPI-1620 & Docetaxel

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.

Group Type EXPERIMENTAL

SPI-1620

Intervention Type DRUG

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

Docetaxel

Intervention Type DRUG

Docetaxel: 75 mg/m2 administered as IV infusion.

Randomized Part: SPI-1620 & Docetaxel

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.

Group Type EXPERIMENTAL

SPI-1620

Intervention Type DRUG

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

Docetaxel

Intervention Type DRUG

Docetaxel: 75 mg/m2 administered as IV infusion.

Randomized Part: Docetaxel

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

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel: 75 mg/m2 administered as IV infusion.

Interventions

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SPI-1620

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

Intervention Type DRUG

Docetaxel

Docetaxel: 75 mg/m2 administered as IV infusion.

Intervention Type DRUG

Other Intervention Names

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Taxotere

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oncology Hematology Care Inc.

Cincinnati, Ohio, United States

Site Status

Tennessee Oncology PLLC

Chattanooga, Tennessee, United States

Site Status

Tennessee Oncology

Nashville, Tennessee, United States

Site Status

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SPI-1620-12-201

Identifier Type: -

Identifier Source: org_study_id