Spots Global Cancer Trial Database for A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
Official Title: 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
Study ID: NCT03707028
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Min-Hee Ryu, Dr.
Affiliation: Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR
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