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

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ClinicalTrials.gov Identifier: NCT01741155
Recruitment Status : Terminated (The study did not meet efficacy end point and did not enroll patients in the randomized phase.)
First Posted : December 4, 2012
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE November 27, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Objective Response Rate(ORR) of SPI-1620 [ Time Frame: Up to 2 years ]
To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • Duration of Response (DoR) [ Time Frame: Up to 12 weeks ]
    only in Randomized Part.
  • Progression-free survival(PFS) [ Time Frame: 2 years from the start of study treatment ]
    only in Randomized Part
  • Overall survival (OS) [ Time Frame: 2 years from the start of study treatment ]
  • Safety of SPI-1620 [ Time Frame: Up to 2 years ]
    Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Drug: SPI-1620 & Docetaxel

    Single Arm & Randomized Part:

    On Day 1, the patient will receive standard docetaxel premedication followed by SPI-1620 11 μg/m2 administered intravenously over one minute. Patients will receive docetaxel 10 (±2) minutes following the infusion of SPI-1620. Docetaxel dose is 75 mg/m2 infusion. Patients will continue to receive SPI-1620 plus docetaxel once every 3 weeks until disease progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses are observed in this group then the Randomized Part will be initiated. About 100 patient in the experimental arm will receive SPI-1620 & Docetaxel

    Other Name: Docetaxel (Taxotere)
  • Drug: Docetaxel

    Randomized Part-Control Arm (100 patient):

    On Day 1 the patient will receive standard docetaxel premedication followed by docetaxel 75 mg/m2 by infusion over 1 hour. Patients will continue to receive docetaxel once every 3 weeks until disease progression or intolerable toxicity.

    Other Name: Taxotere
Study Arms  ICMJE
  • Experimental: SPI-1620 & Docetaxel

    Single Arm and Randomized Part:

    SPI-1620: 11μg/m2 Docetaxel: 75 mg/m2

    Intervention: Drug: SPI-1620 & Docetaxel
  • Active Comparator: Docetaxel
    Randomized Part only Docetaxel: 75 mg/m2 on Day 1 in 3-week cycles
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 20, 2016)
34
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
227
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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 CNS metastases
  • Significant circulatory disorders in the past 6 mo.
  • Concomitant treatment with phosphodiesterase inhibitors
  • Uncontrolled orthostatic hypotension, asthma or COPD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741155
Other Study ID Numbers  ICMJE SPI-1620-12-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spectrum Pharmaceuticals, Inc
Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP