A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

NCT01823835 on ClinicalTrials.gov Phase 1/2 Genentech, Inc. (industry) Started 2014-12-29 Terminated

Riskier than 66% of active trials

Model scores of the 29,894 trials active now.

Model score 19% 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 29% of the time (655 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 2020-03-13, after 2014-12-29 start.

Reason given by the sponsor: “business”

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 2020-03-13. 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: boweldiseaseradiationresectioncancer
Phrases that lowered it: participantspharmacodynamicspharmacokineticsreceptorhiv infection
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past termination rate: 7.0% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Number of arms: 15 (lowers risk) · Design
Sponsor's past trials: 200 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Blinding: none (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Keywords listed: 0 (raises risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 5% (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: 95% (raises risk) · Drug's FDA history
Collaborators: 0 (raises 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: 1/2 (typical: 2)
Number of arms: 15 (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: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 200 (typical: 32)
Sponsor's past termination rate: 7.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 37 (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: 20 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13 (typical: 412.5)
Drug's FAERS reports marked serious: 95% (typical: 85.6%)
Drug's FAERS reports with a death: 5% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: palbociclib, phenyl

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

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A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer NCT02684032 · started 2016 · scored riskier than 32% of active trials completed
Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy NCT01437566 · started 2011 · scored riskier than 69% of active trials completed
A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer NCT02316509 · started 2015 · scored riskier than 44% of active trials completed
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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.