A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-09-29, after 2016-10-31 start.
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 2021-09-29. 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
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cellsubjects withleftpatientsubject
Phrases that lowered it: hcvhepatitislymphomaopen labelml -
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 23.6% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports before start: 209888 (lowers risk) · Drug's FDA history
-
Maximum age: 70 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 41868 (lowers risk) · Drug's FDA history
-
Collaborators: 1 (raises risk) · Design
-
Drug's FAERS reports marked serious: 93.1% (raises risk) · Drug's FDA history
-
Responsible party: sponsor (lowers risk) · Design
-
Number of arms: 1 (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 (typical: 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
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 7 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 209888 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 41868 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- cisplatin, cytarabine, dexamethasone, gemcitabine, oxaliplatin, rituximab, selinexor
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
- Phase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma NCT03212937 · started 2016 · scored riskier than 83% of active trials completed
- KPT-330 Plus RICE for Relapsed/Refractory Aggressive B-Cell Lymphoma NCT02471911 · started 2015 · scored riskier than 86% of active trials completed
- Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma NCT02186834 · started 2014 · scored riskier than 92% of active trials completed
- A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients NCT04811196 · started 2021 · scored riskier than 26% of active trials completed
- A Phase I Dose Escalation Study of Selinexor Plus Nivolumab and Ipilimumab in Advanced/Metastatic Solid Malignancies NCT04850755 · started 2021 · scored riskier than 18% 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.