A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
Model scores of the 29,894 trials active now.
Model score 31% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-07-15, after 2020-01-16 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2022-07-15. 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: breast cancermetastaticher2tumorprostate
Phrases that lowered it: participantsopen labelevaluate theinclusion exclusionto evaluate -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 36.4% (lowers risk) · Drug's FDA history
-
Keywords listed: 48 (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: 4.9% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: none (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 48 (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
- 6 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 4812 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1835 (typical: 412.5)
- Drug's FAERS reports marked serious
- 36.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, digestive, dermatology, urogenital, endocrine
- Drugs matched to FDA substances
- rucaparib, rucaparib camsylate
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 of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II) NCT01482715 · started 2011 · scored riskier than 65% of active trials completed
- A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES) NCT03824704 · started 2019 · scored riskier than 67% of active trials terminated
- A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR) NCT03992131 · started 2019 · scored riskier than 44% of active trials terminated
- Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair NCT03318445 · started 2018 · scored riskier than 36% of active trials completed
- A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature NCT02505048 · started 2016 · scored riskier than 86% 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.