A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

NCT00975182 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2009-09-30 Completed

Riskier than 22% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 2014-09-30, after 2009-09-30 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 2014-09-30. 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

Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: nsclccell lunglung cancersmall cellpatients
Phrases that lowered it: open labelpharmacokineticssafetyphasesystemic
Drug's FAERS reports with a death: 28.4% (raises risk) · Drug's FDA history
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 99.1% (raises risk) · Drug's FDA history
Number of arms: 1 (raises risk) · Design
Blinding: none (lowers 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: 1 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (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: 63 (typical: 32)
Sponsor's past termination rate: 9.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 50 (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: 816 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 295 (typical: 412.5)
Drug's FAERS reports marked serious: 99.1% (typical: 85.6%)
Drug's FAERS reports with a death: 28.4% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: erlotinib

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 Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer NCT00974584 · started 2009 · scored riskier than 45% of active trials completed
A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors NCT01301716 · started 2011 · scored riskier than 25% of active trials completed
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors NCT01562275 · started 2012 · scored riskier than 19% of active trials completed
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors NCT01875705 · started 2013 · scored riskier than 16% of active trials completed
A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors NCT02471846 · started 2015 · scored riskier than 21% 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.