A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

NCT01995188 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2013-12-16 Completed

Riskier than 20% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 2% 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 2016-11-09, after 2013-12-16 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 2016-11-09. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: platinumpriorlung cancerchemotherapynsclc
Phrases that lowered it: participantsopen labelpharmacokineticswill evaluatestudy will
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: 29.2% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 48 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 165 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 95.4% (raises risk) · Drug's FDA history
Keywords listed: 0 (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports before start: 52685 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 8558 (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: 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: 165 (typical: 32)
Sponsor's past termination rate: 7.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 48 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 52685 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8558 (typical: 412.5)
Drug's FAERS reports marked serious: 95.4% (typical: 85.6%)
Drug's FAERS reports with a death: 29.2% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: bevacizumab, carboplatin

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

Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer NCT01363947 · started 2011 · scored riskier than 21% of active trials completed
A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC) NCT01991210 · started 2014 · scored riskier than 34% of active trials terminated
Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer NCT02358200 · started 2015 · scored riskier than 34% of active trials terminated
A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer NCT02826161 · started 2016 · scored riskier than 61% of active trials terminated
Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer NCT02027428 · started 2014 · scored riskier than 58% 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.