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Pazopanib Maintenance for SCLC

Primary Purpose

SCLC

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pazopanib
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCLC focused on measuring pazopanib maintenance, efficacy, SCLC

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pazopanib

placebo

Arm Description

pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC

placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Full Information

First Posted
February 21, 2013
Last Updated
December 5, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01797874
Brief Title
Pazopanib Maintenance for SCLC
Official Title
Phase II Study of Pazopanib Maintenance for SCLC
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCLC
Keywords
pazopanib maintenance, efficacy, SCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pazopanib
Arm Type
Experimental
Arm Description
pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo arm
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Pazopanib Maintenance for SCLC

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