Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer

NCT01548144 on ClinicalTrials.gov Phase 1 M.D. Anderson Cancer Center (academic or other) Started 2012-04-30 Terminated

Riskier than 79% of active trials

Model scores of the 29,894 trials active now.

Model score 22% 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 11% of the time (918 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

Terminated on 2021-08-26, after 2012-04-30 start.

Reason given by the sponsor: “other”

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 2021-08-26. 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: patients mustcellcancerpatientagents
Phrases that lowered it: armpfsafety ofwithin weekswith advanced
Sponsor's past termination rate: 28.5% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 158 (lowers risk) · Sponsor's track record
Sponsor's past trials: 340 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 26.1% (raises risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 88.0% (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 2398 (lowers risk) · Drug's FDA history

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: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 12 (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: academic or other
Sponsor's past trials: 340 (typical: 32)
Sponsor's past termination rate: 28.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 158 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 7056 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2398 (typical: 412.5)
Drug's FAERS reports marked serious: 88.0% (typical: 85.6%)
Drug's FAERS reports with a death: 26.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: crizotinib, pazopanib, 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

A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population NCT01313663 · started 2011 · scored riskier than 41% of active trials terminated
S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib NCT02134912 · started 2014 · scored riskier than 81% of active trials terminated
A Phase I, Open-label, Study of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors NCT00678977 · started 2008 · scored riskier than 20% of active trials completed
BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer NCT01263782 · started 2011 · scored riskier than 97% of active trials completed
Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus) NCT02331251 · started 2014 · scored riskier than 99% of active trials terminated

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.