Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 4% 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
Completed on 2016-03-31, after 2010-08-31 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 2016-03-31. 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: heartfailurechronicuncontrolledcongestive
Phrases that lowered it: patients whoinfectedinvestigatorreceivedlipid -
Sponsor's past termination rate: 1.8% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 75 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 282 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
-
Maximum age: not given (raises risk) · Who can join
-
Responsible party: sponsor (lowers risk) · Design
-
Drug's FAERS reports with a death: 21.5% (raises risk) · Drug's FDA history
-
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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (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
- 282 (typical: 32)
- Sponsor's past termination rate
- 1.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 75 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 16222 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3746 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- cisplatin, everolimus, gemcitabine
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
- Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium NCT00805129 · started 2008 · scored riskier than 49% of active trials completed
- RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder NCT01259063 · started 2010 · scored riskier than 52% of active trials completed
- Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy NCT00949949 · started 2009 · scored riskier than 41% of active trials completed
- Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer NCT02504892 · started 2015 · scored riskier than 94% of active trials terminated
- Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer NCT02228681 · started 2015 · scored riskier than 47% 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.