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Clinical Trial Summary

This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination.


Clinical Trial Description

Primary Phase I Objectives - To determine the RP2D dose of rivoceranib in combination with paclitaxel. Primary Phase II Objectives - To determine clinical activity of the combination of rivoceranib and paclitaxel. Secondary Phase I Objectives - To evaluate the PK of rivoceranib and paclitaxel when given in combination. - To assess the efficacy of rivoceranib in combination with paclitaxel. Secondary Phase II Objectives - To assess the efficacy of rivoceranib in combination with paclitaxel. - To assess the safety and tolerability of rivoceranib in combination with paclitaxel. - To assess the PK of rivoceranib and paclitaxel when given in combination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03707028
Study type Interventional
Source Elevar Therapeutics
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 1, 2018
Completion date August 24, 2021

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