Evidence map›Paper›PMID 39096398›Full record

ArticleInvestigational new drugs2024

A phase I safety and efficacy clinical trial of plocabulin and gemcitabine in patients with advanced solid tumors.

Mohammad H Ghalib, Mariano Provencio Pulla, Maria J De Miguel Luken, Virginia Calvo de Juan, Imran Chaudhary, M Bakri Hammami, Sindhu Vikash, Radhashree Maitra, Sara Martinez, Carmen Kahatt and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Investigational new drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Mohammad H GhalibMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.
Mariano Provencio PullaDept. Servicio de Oncología Médica, University Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.
Maria J De Miguel LukenEarly Phase Clinical Trial Unit, Hospital Madrid Norte San Chinarro - Centro Integral Oncologico Clara Campal, Madrid, Spain.
Virginia Calvo de JuanMedical Oncology Department, University Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.
Imran ChaudharyMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.
M Bakri HammamiMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.
Sindhu VikashMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.
Radhashree MaitraMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.
Sara MartinezClinical Development, PharmaMar, Colmenar Viejo, Madrid, S.A, Spain.
Carmen KahattClinical Development, PharmaMar, Colmenar Viejo, Madrid, S.A, Spain.
Sonia ExtremeraClinical Development, PharmaMar, Colmenar Viejo, Madrid, S.A, Spain.
Salvador FudioClinical Development, PharmaMar, Colmenar Viejo, Madrid, S.A, Spain.
Sanjay GoelMontefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA. sanjay.goel@rutgers.edu.ORCID 0000-0002-2798-7568

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Plocabulin (Plo) induces depolymerization of tubulin fibers with disorganization and fragmentation of the microtubule network leading to mitosis. Plo combined with gemcitabine (Gem) showed synergistic anti-tumor activity in preclinical studies. This phase I trial evaluated the safety, pharmacokinetics (PK) and efficacy of Plo 10-min infusion plus Gem on Day 1 and 8 every 3-week in patients with advanced solid tumors. Fifty-seven patients were enrolled into 8 dose levels (DLs); 74%: females; 74%: ECOG performance status 1; median age: 62 years; median number of prior lines of therapy:3. Dose-limiting toxicities (DLT) in Cycle 1 were grade (G) 3 intestinal obstruction at the maximum tolerated dose (MTD), G3 peripheral sensory neuropathy (PSN), G3 abdominal pain, and G4 thrombocytopenia (1 patient each). The highest DL (DL8: Plo 10.5 mg/m

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineMaximum Tolerated DoseNeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedTreatment OutcomeDeoxycytidineGemcitabineGemcitabineOvarian cancerPhase IPlocabulin

Identifiers

PMID39096398
PMCPMC11625058

What Socratic holds

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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 Socratic graph.