An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer

NCT00738699 on ClinicalTrials.gov Phase 2 Morphotek (industry) Started 2008-09-30 Terminated

Riskier than 90% of active trials

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 5% 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 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 2012-01-31, after 2008-09-30 start.

Reason given by the sponsor: “efficacy”

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 2012-01-31. 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) (raises risk) · Wording Phrases that raised it: ovarianplatinumchemotherapycancersubject
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacyallergic
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Maximum age: 99 (lowers risk) · Who can join
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
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 17.4% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 1 (raises risk) · Sponsor's track record
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 91.5% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record

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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 99 (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: 1 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (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: 3470 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 837 (typical: 412.5)
Drug's FAERS reports marked serious: 91.5% (typical: 85.6%)
Drug's FAERS reports with a death: 17.4% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital, endocrine
Drugs matched to FDA substances: farletuzumab, paclitaxel

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

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse NCT00849667 · started 2009 · scored riskier than 70% of active trials terminated
Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer NCT01004380 · started 2009 · scored riskier than 46% of active trials completed
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer NCT05613088 · started 2023 · scored riskier than 67% of active trials completed
An Open Label Extension Study of the Efficacy of MORAb-003 NCT01018563 · started 2010 · scored riskier than 84% of active trials terminated
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer NCT02289950 · started 2015 · 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.