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

Sponsor
Spectrum Pharmaceuticals, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT01741155
Collaborator
(none)
34
Enrollment
5
Locations
3
Arms
26
Actual Duration (Months)
6.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Drug: Docetaxel
Docetaxel: 75 mg/m2 administered as IV infusion.
Other Names:
  • Taxotere

    		•
    Experimental: 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.

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

    Drug: Docetaxel
    Docetaxel: 75 mg/m2 administered as IV infusion.
    Other Names:
  • Taxotere

    		•
    Active Comparator: Randomized Part: Docetaxel

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

    Drug: Docetaxel
    Docetaxel: 75 mg/m2 administered as IV infusion.
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate(ORR) of SPI-1620 [Up to 2 years]

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

    Secondary Outcome Measures

    1. Duration of Response (DoR) [Up to 12 weeks]

      only in Randomized Part.

    2. Progression-free survival(PFS) [2 years from the start of study treatment]

      only in Randomized Part

    3. Overall survival (OS) [2 years from the start of study treatment]

    4. Safety of SPI-1620 [Up to 2 years]

      Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oncology Hematology Care Inc. Cincinnati Ohio United States 45242
    2 Tennessee Oncology PLLC Chattanooga Tennessee United States 37404
    3 Tennessee Oncology Nashville Tennessee United States 37203
    4 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    5 Virginia Cancer Institute Richmond Virginia United States 23230

    Sponsors and Collaborators

    • Spectrum Pharmaceuticals, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spectrum Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT01741155
    Other Study ID Numbers:
    • SPI-1620-12-201
    First Posted:
    Dec 4, 2012
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Oct 13, 2021