A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

NCT02136524 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2014-04-30 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 1% for any early termination, 0% 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 2014-05-31, after 2014-04-30 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 2014-05-31. 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) (lowers risk) · Wording Phrases that raised it: adequateiirenalfunctionsignificant
Phrases that lowered it: participantshealthytabletsingle dosebioavailability
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Primary purpose: not given (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 44 (lowers risk) · Sponsor's track record
Maximum age: 55 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: 4.2% (lowers risk) · Drug's FDA history
Disease area, psychiatry: No (lowers risk) · Disease area
Sponsor's past trials: 177 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area

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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: not given (typical: 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: 55 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 177 (typical: 32)
Sponsor's past termination rate: 7.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 44 (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: 24 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 22 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 4.2% (typical: 15.9%)

Disease area and drugs

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

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 Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants NCT01929876 · started 2013 · scored riskier than 1% of active trials completed
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants NCT01277718 · started 2011 · scored riskier than 1% of active trials completed
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations NCT02596100 · started 2015 · scored riskier than 0% of active trials completed
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition NCT04549480 · started 2020 · scored riskier than 0% of active trials completed
A Relative Bioavailability Study of Two Formulations of BCX7353 NCT03202784 · started 2017 · scored riskier than 0% 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.