A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors

NCT01494688 on ClinicalTrials.gov Phase 1 Hoffmann-La Roche (industry) Started 2011-12-20 Completed

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 5% of the time (4,470 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 2018-02-07, after 2011-12-20 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 2018-02-07. 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

Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: breast cancermetastaticher2locallycell
Phrases that lowered it: participantsparticipantreceiptvirusopen
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 94.8% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 206 (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Collaborators: 0 (raises risk) · Design

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: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (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: 476 (typical: 32)
Sponsor's past termination rate: 10.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 206 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 7954 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1929 (typical: 412.5)
Drug's FAERS reports marked serious: 94.8% (typical: 85.6%)
Drug's FAERS reports with a death: 18.4% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: emactuzumab, paclitaxel

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 First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia NCT01462175 · started 2011 · scored riskier than 27% of active trials completed
A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors NCT02323191 · started 2015 · scored riskier than 15% of active trials completed
A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors NCT04158583 · started 2019 · scored riskier than 18% of active trials terminated
A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors NCT02650713 · started 2016 · scored riskier than 24% of active trials completed
A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) NCT02627274 · started 2015 · scored riskier than 24% 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.