A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)

NCT01684202 on ClinicalTrials.gov Phase 2 Otsuka Pharmaceutical Co., Ltd. (industry) Started 2012-07-31 Completed

Riskier than 20% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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 13% of the time (1,304 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2014-06-30, after 2012-07-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2014-06-30. 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

Minimum age: 20 (lowers risk) · Who can join
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 4.9% (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 33.5% (raises risk) · Drug's FDA history
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: 80 (lowers risk) · Who can join
Number of arms: 1 (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cancerdlchemotherapypriortumor
Phrases that lowered it: subjectspharmacokineticsand safetyperiodto investigate
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Responsible party: sponsor (lowers risk) · Design
Collaborators: 0 (raises risk) · Design

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: 2
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 41 (typical: 32)
Sponsor's past termination rate: 4.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 12 (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: 355 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 237 (typical: 412.5)
Drug's FAERS reports marked serious: 89.6% (typical: 85.6%)
Drug's FAERS reports with a death: 33.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: tolvaptan

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

A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg NCT01048788 · started 2009 · scored riskier than 11% of active trials completed
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema NCT01114828 · started 2010 · scored riskier than 8% of active trials completed
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema NCT01050530 · started 2009 · scored riskier than 9% of active trials completed
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration NCT01876381 · started 2013 · scored riskier than 8% of active trials completed
Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer NCT01423903 · started 2010 · scored riskier than 41% 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.