TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 14% 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 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-12-22, after 2018-11-12 start.
Reason given by the sponsor: “enrollment”
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 2023-12-22. 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: cancerchemotherapyadvancedpriortherapy
Phrases that lowered it: patientsopen labelformulationhepaticdrug -
Sponsor's past termination rate: 3.0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 93.6% (raises risk) · Drug's FDA history
-
Sponsor's past trials: 66 (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 10 (raises risk) · Sponsor's track record
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports with a death: 21.0% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 11064 (lowers risk) · Drug's FDA history
-
Number of arms: 2 (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
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 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
- 66 (typical: 32)
- Sponsor's past termination rate
- 3.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (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
- 54322 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11064 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- doxorubicin
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 Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer NCT01815294 · started 2013 · scored riskier than 23% of active trials completed
- A Study of Doxorubicin Hydrochloride Liposome Injection in Subjects With Ovarian Cancer. NCT03681548 · started 2018 · scored riskier than 9% of active trials completed
- Combination Study Of SB-485232 (Interleukin 18) And Doxil For Advanced Stage Epithelial Ovarian Cancer NCT00659178 · started 2008 · scored riskier than 51% of active trials completed
- Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors NCT01214668 · started 2009 · scored riskier than 20% of active trials completed
- MK-4827 in Combination With Pegylated Liposomal Doxorubicin in Participants With Advanced Solid Tumors and Ovarian Cancer (MK-4827-011) NCT01227941 · started 2010 · scored riskier than 43% of active trials terminated
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.