A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)

NCT01100931 on ClinicalTrials.gov Phase 1/2 National Cancer Institute (NCI) (government) Started 2010-02-28 Completed

Riskier than 79% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (96 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 2012-12-31, after 2010-02-28 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 2012-12-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: lung cancercell lungsmall cellpaclitaxelnon small
Phrases that lowered it: participantstrialadvancedcarcinomareceived
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past termination rate: 7.0% (lowers risk) · Sponsor's track record
Sponsor's past trials: 356 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 17.8% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 215 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: government (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Disease area, dermatology: No (lowers risk) · Disease area

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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 6 (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: government (typical: academic or other)
Sponsor's past trials: 356 (typical: 32)
Sponsor's past termination rate: 7.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 215 (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: 13738 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2769 (typical: 412.5)
Drug's FAERS reports marked serious: 92.1% (typical: 85.6%)
Drug's FAERS reports with a death: 17.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, respiratory
Drugs matched to FDA substances: carboplatin, paclitaxel, sepantronium

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

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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
Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer NCT02402920 · started 2015 · scored riskier than 86% of active trials completed
TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003) NCT02920476 · started 2017 · scored riskier than 86% of active trials completed
Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC) NCT00942825 · started 2009 · scored riskier than 82% 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.