Trial reportCancer medicine2026
Phase II Trial of Opaganib Addition in Metastatic Castration-Resistant Prostate Cancer After Disease Progression on Abiraterone or Enzalutamide.
Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04207255 (A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
introductionOpaganib is a first-in-class oral sphingolipid metabolism inhibitor that inhibits sphingosinekinase 2 (SphK2) and dihydroceramide desaturase (DES) and that has a demonstrated safety and preliminary anti-cancer activity signal in a Phase I study.
methodsIn this phase II trial, patients with metastatic castration-resistant prostate cancer who had disease progression on novel hormonal agents (NHAs) abiraterone or enzalutamide were enrolled and treated with opaganib while continuing their NHA. After safety lead-in cohorts, the trial enrolled cohort 2 (abiraterone + opaganib 500 mg Q 12 h) and cohort 3 (enzalutamide + opaganib 500 mg Q 12 h). The primary efficacy endpoint was the proportion of patients with disease control at Day 113. The postulated disease control rate was 10%. Secondary efficacy endpoints include prostate-specific antigen (PSA) progression-free survival (PSA-PFS) and PSA response rates. The primary safety endpoint was the incidence of adverse events (AEs).
resultsThe disease control rates were 15% (95% CI = 4%-35%, 4 of 26 patients) in cohort 2 and 9% (95% CI = 2%-24%, 3 of 34 patients) in cohort 3. The median PSA-PFS was 56 days (95% CI = 35-112 days) in cohort 2 and 55 days (95% CI = 35-56 days) in cohort 3. The most common AEs of grade 3 or higher were hypertension (8%) and musculoskeletal AEs (8%) in cohort 2 and grade 3 anemia (18%) in cohort 3.
conclusionThe trial did not meet its primary objective of demonstrating 30% disease control at 113 days. However, subjects who experienced a PSA response or stabilization warrant further exploration for biomarkers of response.
trial registrationClinicalTrials.gov number: NCT04207255.
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