Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma

NCT01144169 on ClinicalTrials.gov Phase 1 University of Pittsburgh (academic or other) Started 2010-10-31 Terminated

Riskier than 59% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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

Terminated on 2016-09-30, after 2010-10-31 start.

Reason given by the sponsor: “enrollment”

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 2016-09-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: psoriasiscancerto determinepatientspotential
Phrases that lowered it: criteria subjectssubjects whohivpharmacokineticinteraction
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports marked serious: 50.7% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 5.3% (lowers risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Minimum age: 19 (lowers risk) · Who can join
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 92 (lowers risk) · Sponsor's track record
Sponsor's past trials: 197 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Number of arms: 1 (raises risk) · Design
Collaborators: 1 (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: 1 (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: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 4 (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: academic or other
Sponsor's past trials: 197 (typical: 32)
Sponsor's past termination rate: 8.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 92 (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: 8996 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1774 (typical: 412.5)
Drug's FAERS reports marked serious: 50.7% (typical: 85.6%)
Drug's FAERS reports with a death: 5.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: hydroxychloroquine

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

Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC) NCT01550367 · started 2012 · scored riskier than 92% of active trials completed
Biological Effects of Agent on PAR-4 Levels With Resected Solid Tumors NCT03015324 · started 2017 · scored riskier than 76% of active trials completed
Management of Cardiovascular Disease in Kidney Disease (MaCK) Study NCT03636152 · started 2018 · scored riskier than 68% of active trials completed
To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer NCT03215264 · started 2017 · scored riskier than 82% of active trials completed
Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer NCT03037437 · started 2017 · scored riskier than 71% 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.