Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 8% 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 2012-03-31, after 2010-04-30 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 2012-03-31. 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
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Design: factorial (lowers risk) · Design
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Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancermetastaticconcurrentchemotherapyradiation
Phrases that lowered it: accordingupper normalvalueto investigateinvestigate the -
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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports with a death: 23.0% (raises risk) · Drug's FDA history
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Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, dermatology: No (lowers risk) · Disease area
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 6904 (raises 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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not given (typical: randomized)
- Design
- factorial (typical: parallel)
- Primary purpose
- 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
- 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
- 6 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 6904 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1850 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- gemcitabine, pemetrexed
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 Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer NCT01472770 · started 2011 · scored riskier than 58% of active trials completed
- Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy NCT03086538 · started 2017 · scored riskier than 36% of active trials completed
- A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer. NCT01929421 · started 2009 · scored riskier than 84% of active trials completed
- Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations NCT00792363 · started 2008 · scored riskier than 87% of active trials completed
- Temsirolimus and Irinotecan for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations NCT00827684 · started 2009 · scored riskier than 98% 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.