Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

NCT04729608 on ClinicalTrials.gov Phase 3 Aravive, Inc. (industry) Started 2021-04-22 Terminated

Riskier than 97% of active trials

Model scores of the 29,894 trials active now.

Model score 30% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2023-08-04, after 2021-04-22 start.

Reason given by the sponsor: “other”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-08-04. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: platinumprogressioncancerbonemetastases
Phrases that lowered it: receivedose of28administeredfirst dose
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Blinding: triple (raises risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 94.7% (raises risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 8143 (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Collaborators: 2 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 63476 (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 2 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 2 (typical: 32)
Sponsor's past termination rate: 50% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 2 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 63476 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8143 (typical: 412.5)
Drug's FAERS reports marked serious: 94.7% (typical: 85.6%)
Drug's FAERS reports with a death: 19.5% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital, endocrine
Drugs matched to FDA substances: batiraxcept, paclitaxel

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer NCT03639246 · started 2018 · scored riskier than 74% of active trials completed
Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer NCT02659384 · started 2016 · scored riskier than 98% of active trials completed
A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL) NCT03398655 · started 2017 · scored riskier than 65% of active trials completed
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer NCT03414047 · started 2018 · scored riskier than 51% of active trials completed
Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer NCT01196741 · started 2011 · scored riskier than 99% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.