Safety, Tolerability and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced GC or GEJ Cancer.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Primary Phase I Objectives To determine the maximum tolerated dose and recommended Phase 2 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 phar...
Primary Phase I Objectives To determine the maximum tolerated dose and recommended Phase 2 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 pharmacokinetics (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. Exploratory Phase I/II Objectives To evaluate tumor expression of proteins related to paclitaxel resistance at prior to first-line chemotherapy and at prior to this study. To evaluate the correlation between response to treatment and tumor expression of proteins related to paclitaxel resistance.
Tracking Information
- NCT #
- NCT03707028
- Collaborators
- Not Provided
- Investigators
- Study Director: Arlo McGinn, PhD Elevar Therapeutics
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