A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2015-01-31, after 2012-08-31 start.
Reason given by the sponsor: “other”
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 2015-01-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patients mustradiationmg dlcellchemotherapy
Phrases that lowered it: asthmaobjectivereceivedstandard therapyclinical -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 21 (lowers risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 57.3% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 3 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Maximum age: 75 (lowers risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Blinding: none (raises risk) · Design
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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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 3 (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
- 15168 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2996 (typical: 412.5)
- Drug's FAERS reports marked serious
- 57.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- hydroxychloroquine, sirolimus
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
- Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer NCT01266057 · started 2011 · scored riskier than 53% of active trials completed
- A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma NCT00743509 · started 2008 · scored riskier than 99% of active trials completed
- Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment NCT00909831 · started 2008 · scored riskier than 86% of active trials completed
- Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors NCT01634893 · started 2012 · scored riskier than 35% of active trials completed
- Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases NCT01417403 · started 2011 · scored riskier than 78% 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.