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NCT02540356 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02540356 is a Phase 1 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 2 participants.
The verdict
NCT02540356, a Phase 1 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL BAX69 Single-Route Arm
- BIOLOGICAL BAX69 Double-Route Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2016-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02540356
The ClinicalTrials.gov registry entry for NCT02540356 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BAX69 Single-Route Arm is the first listed.
NCT02540356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02540356 about?
NCT02540356 is a clinical study titled "Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer". 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 ...
What is the current status of trial NCT02540356?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-11-02. Estimated completion is 2016-05-26.
What interventions are being tested in trial NCT02540356?
The interventions under investigation include: BAX69 Single-Route Arm (BIOLOGICAL), BAX69 Double-Route Arm (BIOLOGICAL).
Who is sponsoring clinical trial NCT02540356?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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