Episcleral Topotecan for Treatment of Group D Retinoblastoma
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|ClinicalTrials.gov Identifier: NCT04156347|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Drug: Episcleral Topotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Sequestered Transscleral, Controlled-Release Topotecan Delivered From An Episcleral Reservoir In Unilateral Group D Retinoblastoma Eyes|
|Estimated Study Start Date :||December 5, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 14, 2021|
Experimental: Phase I Open Label Study
Phase I Single Arm
Drug: Episcleral Topotecan
Other Name: Sustained Release Episcleral Topotecan
- The primary outcome measure of the study is safety assessment as determined by comprehensive ophthalmic exam that enables determination of maximum tolerated dose. [ Time Frame: 29 Days ]The primary outcome measure of the study is safety assessment as determined by comprehensive ophthalmic exam that enables determination of maximum tolerated dose.
- To determine systemic exposure by measurement of Topotecan in plasma. [ Time Frame: 29 Days ]To characterize the systemic exposure of episcleral topotecan by quantifying topotecan concentration in plasma.
- To preliminarily define the antitumor activity as determine by reduction in maximal height of the tumor in the primary quadrant where the initial Episcleral Topotecan is placed. [ Time Frame: 29 Days ]To preliminarily define the antitumor activity as determine by reduction in maximal height of the tumor in the primary quadrant where the initial Episcleral Topotecan is placed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156347
|Contact: David Carpi, MScemail@example.com|
|Contact: Ricardo Carvalho, MDfirstname.lastname@example.org|