A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 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 2014-04-30, after 2011-11-30 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 2014-04-30. 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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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 12.3% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: radiationpaclitaxelcarboplatincancertumor
Phrases that lowered it: screeningpatientsingledays beforesolid -
Trials the sponsor started in the prior 2 years: 120 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 21.0% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 594 (raises risk) · Sponsor's track record
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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: 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
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 594 (typical: 32)
- Sponsor's past termination rate
- 12.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 120 (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
- 31246 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6376 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- carboplatin, doxorubicin, gemcitabine, iniparib
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 and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors NCT01213381 · started 2010 · scored riskier than 30% of active trials completed
- Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) NCT01082549 · started 2010 · scored riskier than 81% of active trials completed
- SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer NCT01086254 · started 2010 · scored riskier than 88% of active trials completed
- Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients NCT01204125 · started 2010 · scored riskier than 67% of active trials completed
- Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix NCT03644342 · started 2019 · scored riskier than 92% 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.