CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Continuous pazopanib (Arm A) +1 moredrug
Likely dose
Continuous pazopanib (Arm A) 800mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01813136
NCT01813136Phase 2Completed
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A Randomized, Multicenter, Open-label, Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

Centre Leon Berard·interventional·Posted Mar 18, 2013·Updated Aug 16, 2019

In Brief

A Phase 2 clinical trial evaluating Continuous pazopanib (Arm A) and Intermittent pazopanib (Arm B) for Thyroid Carcinoma. Completed, enrolled 168 participants across 13 sites.

Detailed Summary

The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Carcinoma
CountriesFrance
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2013
Enrollment StartMar 1, 2013
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.3 years ago

Interventions

Continuous pazopanib (Arm A)drug

Daily oral administration of pazopanib 800mg (28 days cycles) from randomization until progression (according to RECIST 1.1) under treatment, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization

Intermittent pazopanib (Arm B)drug

Temporary discontinuation of pazopanib at randomization, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization. Pazopanib will be reintroduced for 6 cycles of 28 days, with daily administration of pazopanib 800mg, as soon as the patient relapses (progressive disease according to RECIST 1.1). At the end of this additional 6 cycles, study drug will be stopped a second time. This sequential scheme will be maintained until the patient experiences "on-treatment" progression