NCT01797874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

3.7 years

First QC Date

February 21, 2013

Last Update Submit

December 5, 2019

Conditions

SCLC

Keywords

pazopanib maintenanceefficacySCLC

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    12 months

Study Arms (2)

Pazopanib

EXPERIMENTAL

pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC

Drug: Pazopanib

placebo

PLACEBO COMPARATOR

placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC

Drug: Placebo

Interventions

PazopanibDRUG

Experimental

Also known as: Votrient
Pazopanib
PlaceboDRUG

placebo arm

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • poor hepatic, renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

pazopanib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

KR(1)