Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% 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 2016-10-05, after 2013-06-30 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 2016-10-05. 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: heartanginacardiactherapycolorectal
Phrases that lowered it: malepatientspharmacokineticsthe studyadequate contraception -
Sponsor's past termination rate: 20.9% (raises risk) · Sponsor's track record
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Minimum age: 21 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Maximum age: 99 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 15.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 21 (lowers risk) · Sponsor's track record
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Primary purpose: basic science (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 5839 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 73.1% (raises risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 3 (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 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 43 (typical: 32)
- Sponsor's past termination rate
- 20.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 21 (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
- 20222 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5839 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- curcumin, irinotecan, turmeric
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 Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients NCT01183494 · started 2009 · scored riskier than 76% of active trials completed
- Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors NCT03295084 · started 2015 · scored riskier than 52% of active trials completed
- AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer NCT00535353 · started 2008 · scored riskier than 49% of active trials completed
- Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin NCT00861328 · started 2008 · scored riskier than 41% of active trials completed
- CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin NCT00969033 · started 2009 · scored riskier than 90% 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.