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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: Clinical Trial Phase 1 study, sponsored by Baxalta now part of Shire.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria: - Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure i
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 |
Why NCT02540356 stopped before completion
NCT02540356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which BAX69 Single-Route Arm is the first listed.
NCT02540356 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02540356's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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