Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 9% 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 (851 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 2019-08-26, after 2013-10-23 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 2019-08-26. 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: cancermetastaticcellstudy ofchemotherapy
Phrases that lowered it: participantsdrugweeksarmregorafenib -
Sponsor's past termination rate: 35.3% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Phase: 1/2 (raises risk) · Design
-
Collaborators: 2 (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 48 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports with a death: 25.1% (raises risk) · Drug's FDA history
-
Sponsor's past trials: 133 (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Blinding: none (raises risk) · Design
-
Keywords listed: 8 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 92.0% (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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 8 (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
- 133 (typical: 32)
- Sponsor's past termination rate
- 35.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 48 (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
- 11280 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2681 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- guadecitabine, irinotecan, regorafenib, tipiracil, trifluridine
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
- SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) NCT01966289 · started 2014 · scored riskier than 74% of active trials completed
- A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy NCT03454620 · started 2018 · scored riskier than 72% 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
- Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other Treatments NCT01124630 · started 2010 · scored riskier than 57% 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
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.