NCT02540356

Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer

A Phase 1/2a, Open-Label, Parallel, Two-Arm Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects With Refractory Ovarian Cancer With Malignant Ascites

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.

Conditions

• Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites

Interventions

Type	Name	Description
BIOLOGICAL	BAX69 Single-Route Arm	Intraperitoneal (IP) only
BIOLOGICAL	BAX69 Double-Route Arm	Intravenous (IV) infusion + intraperitoneal (IP) infusion

Timeline

• Start date: 2015-11-02
• Primary completion: 2016-05-26
• Completion: 2016-05-26
• First posted: 2015-09-03
• Last updated: 2021-01-12
• Results posted: 2017-06-15

Locations

6 sites across 1 country: United States