A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
NCT03707028 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-04-11
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.
Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
Rivoceranib
Film-coated tablet
- DRUG
-
Solution administered intravenously
Sponsors & Collaborators
-
Elevar Therapeutics
lead INDUSTRY
Principal Investigators
-
Min-Hee Ryu, Dr. · Asan Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2021-08-24
- Completion
- 2021-08-24
Countries
- South Korea
Study Locations
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