Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva...

NCT01229150 on ClinicalTrials.gov Phase 2 National Cancer Institute (NCI) (government) Started 2010-10-26 Completed

Riskier than 89% of active trials

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (376 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 2015-11-21, after 2010-10-26 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 2015-11-21. 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: heartto determinepatients mustlung cancerqt
Phrases that lowered it: participantsparticipantadvancedantiretroviral20
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past trials: 436 (lowers risk) · Sponsor's track record
Collaborators: 4 (lowers risk) · Design
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 30.7% (raises risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 239 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 98.9% (raises risk) · Drug's FDA history
Sponsor type: government (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Disease area, dermatology: No (lowers risk) · Disease area
Has a data monitoring committee: No (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: 2
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 4 (typical: 0)
Keywords listed: 7 (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: 436 (typical: 32)
Sponsor's past termination rate: 8.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 239 (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: 1420 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 564 (typical: 412.5)
Drug's FAERS reports marked serious: 98.9% (typical: 85.6%)
Drug's FAERS reports with a death: 30.7% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, respiratory
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

Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer NCT01222689 · started 2010 · scored riskier than 74% of active trials completed
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors NCT01217450 · started 2012 · scored riskier than 71% of active trials completed
AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer NCT01287130 · started 2011 · scored riskier than 28% of active trials completed
Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery NCT01206140 · started 2010 · scored riskier than 72% of active trials completed
AZD7451 for Recurrent Gliomas NCT01468324 · started 2011 · scored riskier than 68% 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.