Evidence map›Paper›PMID 35416959›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

A Phase Ib/II Study of Sabizabulin, a Novel Oral Cytoskeleton Disruptor, in Men with Metastatic Castration-resistant Prostate Cancer with Progression on an Androgen Receptor-targeting Agent.

Mark C Markowski, Ronald Tutrone, Christopher Pieczonka, K Gary Barnette, Robert H Getzenberg, Domingo Rodriguez, Mitchell S Steiner, Daniel R Saltzstein, Mario A Eisenberger, Emmanuel S Antonarakis

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
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  11. Article
  12. Low-Data Drug Design with Few-Shot Generative Domain Adaptation.Bioengineering (Basel, Switzerland) · 2023
    Article
  13. Article
  14. Review
  15. Review
  16. Insights for COVID-19 in 2023.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023
    Review
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Mark C MarkowskiSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.ORCID 0000-0003-2780-5100
Ronald TutroneChesapeake Urology Research Associates, Towson, Maryland.ORCID 0000-0001-6705-778X
Christopher PieczonkaAssociated Medical Professionals of NY, Syracuse, New York.ORCID 0000-0002-2531-7587
K Gary BarnetteVeru Inc., Miami, Florida.
Robert H GetzenbergVeru Inc., Miami, Florida.ORCID 0000-0003-0104-8391
Domingo RodriguezVeru Inc., Miami, Florida.
Mitchell S SteinerVeru Inc., Miami, Florida.
Daniel R SaltzsteinUrology San Antonio, San Antonio, Texas.
Mario A EisenbergerSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Emmanuel S AntonarakisSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

purposeSabizabulin, an oral cytoskeleton disruptor, was tested in a phase Ib/II clinical study in men with metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND

methodsThe phase Ib portion utilized a 3+3 design with escalating daily oral doses of 4.5-81 mg and increasing schedule in 39 patients with mCRPC treated with one or more androgen receptor-targeting agents. Prior taxane chemotherapy was allowed. The phase II portion tested a daily dose of 63 mg in 41 patients with no prior chemotherapy. Efficacy was assessed using PCWG3 and RECIST 1.1 criteria.

resultsThe MTD was not defined in the phase Ib and the recommended phase II dose was set at 63 mg/day. The most common adverse events (>10% frequency) at the 63 mg oral daily dosing (combined phase Ib/II data) were predominantly grade 1-2 events. Grade ≥3 events included diarrhea (7.4%), fatigue (5.6%), and alanine aminotransferase/aspartate aminotransferase elevations (5.6% and 3.7%, respectively). Neurotoxicity and neutropenia were not observed. Preliminary efficacy data in patients treated with ≥1 continuous cycle of 63 mg or higher included objective response rate in 6 of 29 (20.7%) patients with measurable disease (1 complete, 5 partial) and 14 of 48 (29.2%) patients had PSA declines. The Kaplan-Meier median radiographic progression-free survival was estimated to be 11.4 months (n = 55). Durable responses lasting >2.75 years were observed.

conclusionsThis clinical trial demonstrated that chronic oral daily dosing of sabizabulin has a favorable safety profile with preliminary antitumor activity. These data support the ongoing phase III VERACITY trial of sabizabulin in men with mCRPC.

Indexed as

Antineoplastic AgentsCytoskeletonProstatic Neoplasms, Castration-ResistantHumansMaleProgression-Free SurvivalProstate-Specific AntigenReceptors, AndrogenTreatment OutcomeAntineoplastic AgentsProstate-Specific AntigenReceptors, Androgen

Identifiers

PMID35416959
PMCPMC9774054

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.