BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours

NCT01169675 on ClinicalTrials.gov Phase 1 Boehringer Ingelheim (industry) Started 2010-07-31 Completed

Riskier than 18% of active trials

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 2012-11-30, after 2010-07-31 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 2012-11-30. 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
Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: solidtumorsventricularbrainnsclc
Phrases that lowered it: efficacycombinationsafety ofdrugsalcohol
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 180 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 90 (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Number of arms: 6 (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: 6 (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: 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: 90 (typical: 32)
Sponsor's past termination rate: 4.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 180 (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: 3118 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1128 (typical: 412.5)
Drug's FAERS reports marked serious: 91.3% (typical: 85.6%)
Drug's FAERS reports with a death: 25.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer
Drugs matched to FDA substances: afatinib, pemetrexed

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

Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours. NCT00998296 · started 2009 · scored riskier than 29% of active trials completed
Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours NCT00716417 · started 2008 · scored riskier than 20% of active trials completed
LUX-Lung 5: Afatinib Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following Afatinib Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib NCT01085136 · started 2010 · scored riskier than 38% of active trials completed
An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours NCT01206816 · started 2010 · scored riskier than 13% of active trials completed
Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC NCT00824408 · started 2009 · scored riskier than 49% 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.