Clincosm LogoSign in Get a demo

Pazopanib Maintenance for SCLC

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01797874
Collaborator
(none)
97
Enrollment
1
Location
2
Arms
54
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Pazopanib Maintenance for SCLC
Actual Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pazopanib

pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC

Drug: Pazopanib
Experimental
Other Names:
  • Votrient

    		•
    Placebo Comparator: placebo

    placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC

    Drug: Placebo
    placebo arm

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • histologically confirmed SCLC

    • no disease progression after 4 cycles of etoposide/platinum 1st-line therapy

    • history of 4 cycles of etoposide/platinum 1st-line therapy

    • between 21 days and 42 days since C4D1 of etoposide/platinum

    • no symptomatic brain meta

    Exclusion Criteria:
    • poor hepatic, renal function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myung-Ju Ahn, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01797874
    Other Study ID Numbers:
    • 2012-09-060-002
    First Posted:
    Feb 25, 2013
    Last Update Posted:
    Dec 9, 2019
    Last Verified:
    Dec 1, 2019
    Keywords provided by Myung-Ju Ahn, Professor, Samsung Medical Center
    pazopanib maintenance
    efficacy
    SCLC
    Additional relevant MeSH terms:
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Dec 9, 2019