Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 11% 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
Completed on 2016-08-25, after 2014-12-29 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 2016-08-25. 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: metastaticcapecitabinecombinationcancertherapy
Phrases that lowered it: patients2arandomizedbowelperiod -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 29.8% (raises risk) · Drug's FDA history
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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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Blinding: none (raises risk) · Design
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Keywords listed: 0 (raises risk) · Design
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Drug's FAERS reports before start: 37587 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 37587 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4459 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- capecitabine, lapatinib
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
- Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer NCT00807859 · started 2009 · scored riskier than 62% of active trials completed
- A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC) NCT01702558 · started 2012 · scored riskier than 85% of active trials terminated
- A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy. NCT01290718 · started 2011 · scored riskier than 49% of active trials terminated
- Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer NCT00820222 · started 2009 · scored riskier than 56% of active trials completed
- A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer NCT02144012 · started 2014 · scored riskier than 15% 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.