Clinical Trials Directory

Trials / Terminated

TerminatedNCT03707028

A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Elevar Therapeutics · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGRivoceranibFilm-coated tablet
DRUGPaclitaxelSolution administered intravenously

Timeline

Start date
2018-10-01
Primary completion
2021-08-24
Completion
2021-08-24
First posted
2018-10-16
Last updated
2022-04-11

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03707028. Inclusion in this directory is not an endorsement.