A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

NCT03707028 on ClinicalTrials.gov Phase 1/2 Elevar Therapeutics (industry) Started 2018-10-01 Terminated

Riskier than 45% of active trials

Model scores of the 29,894 trials active now.

Model score 16% 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 29% of the time (655 trials).

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

How it ended

Terminated on 2021-08-24, after 2018-10-01 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 2021-08-24. 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: metastaticcarcinomamseccancerto determine
Phrases that lowered it: participantparticipantsinvestigatorsinglediseases
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: not given (lowers risk) · Design
Minimum age: 19 (lowers risk) · Who can join
Design: single group (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 1 (raises risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Drug's FAERS reports marked serious: 94.2% (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: 21.7% (raises risk) · Drug's FDA history
Drug's FAERS reports before start: 42170 (lowers risk) · Drug's FDA history

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: 1/2 (typical: 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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 19 (typical: 18)
Maximum age: not given (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: 1 (typical: 32)
Sponsor's past termination rate: 0% (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: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 42170 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8562 (typical: 412.5)
Drug's FAERS reports marked serious: 94.2% (typical: 85.6%)
Drug's FAERS reports with a death: 21.7% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: apatinib, paclitaxel, rivoceranib

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 Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC) NCT04073615 · started 2019 · scored riskier than 47% of active trials terminated
Study With Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy NCT03762564 · started 2019 · scored riskier than 78% of active trials completed
Multicenter Dose-escalation Study of a Combination of Pazopanib and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma or Others Advanced Solid Tumors NCT01202032 · started 2010 · scored riskier than 29% of active trials completed
Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation NCT03829410 · started 2019 · scored riskier than 64% of active trials completed
Safety Study of Regorafenib With PF-03446962 to Treat Colorectal Cancer NCT02116894 · started 2014 · scored riskier than 61% 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.