Evidence map›Paper›PMID 31471863›Full record

ArticleInvestigational new drugs2020

A Phase 1 study of BAL101553, a novel tumor checkpoint controller targeting microtubules, administered as 48-h infusion in adult patients with advanced solid tumors.

Markus Joerger, Anastasios Stathis, Yannis Metaxas, Dagmar Hess, Mara Mantiero, Michael Mark, Matthias Volden, Thomas Kaindl, Marc Engelhardt, Patrice Larger and 6 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Updates in IDH-Wildtype Glioblastoma.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  5. 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

16 authors.

Markus JoergerCantonal Hospital St. Gallen, St. Gallen, Switzerland.
Anastasios StathisOncology Institute of Southern Switzerland, Bellinzona, Switzerland.
Yannis MetaxasDepartment of Medical Oncology, Cantonal Hospital Graubünden, Chur, Switzerland.
Dagmar HessCantonal Hospital St. Gallen, St. Gallen, Switzerland.
Mara MantieroOncology Institute of Southern Switzerland, Bellinzona, Switzerland.
Michael MarkDepartment of Medical Oncology, Cantonal Hospital Graubünden, Chur, Switzerland.
Matthias VoldenCantonal Hospital St. Gallen, St. Gallen, Switzerland.
Thomas KaindlBasilea Pharmaceutica International Ltd, Grenzacherstrasse 487, PO Box, CH-4005, Basel, Switzerland. Thomas.Kaindl@basilea.com.
Marc EngelhardtBasilea Pharmaceutica International Ltd, Grenzacherstrasse 487, PO Box, CH-4005, Basel, Switzerland.
Patrice LargerBasilea Pharmaceutica International Ltd, Grenzacherstrasse 487, PO Box, CH-4005, Basel, Switzerland.
Heidi LaneBasilea Pharmaceutica International Ltd, Grenzacherstrasse 487, PO Box, CH-4005, Basel, Switzerland.
Peter HafnerBasilea Pharmaceutica International Ltd, Grenzacherstrasse 487, PO Box, CH-4005, Basel, Switzerland.
Nicole LevySwiss Group for Clinical Cancer Research, Bern, Switzerland.
Silvia StuedeliSwiss Group for Clinical Cancer Research, Bern, Switzerland.
Cristiana SessaOncology Institute of Southern Switzerland, Bellinzona, Switzerland.
Roger von MoosDepartment of Medical Oncology, Cantonal Hospital Graubünden, Chur, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose BAL101553, the prodrug of the microtubule-destabilizer BAL27862, previously showed signs of antitumor activity when administered as a 2-h infusion, but its use was limited by vascular toxicity. We investigated an alternative dosing strategy aimed at improving the safety profile of BAL101553. Methods This multicenter, open-label, Phase 1 dose-escalation study used a 3 + 3 design to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), pharmacokinetics, and antitumor activity of BAL101553 administered as a 48-h IV infusion on Days 1, 8, and 15 of a 28-day cycle. Patients received oral BAL101553 on Days 15-21 of cycle 2 to assess oral bioavailability. Results BAL101553 was well tolerated at doses up to ≤70 mg/m

Indexed as

Administration, OralAdultAgedAntineoplastic AgentsBenzimidazolesFemaleHumansInfusions, IntravenousMaleMaximum Tolerated DoseMicrotubulesMiddle AgedNeoplasmsOxadiazolesProdrugsTreatment OutcomeAntineoplastic AgentsBAL27862BenzimidazoleslisavanbulinOxadiazolesProdrugsBAL101553ChemotherapyMicrotubule-targeting agentOvarian cancer

Identifiers

PMID31471863
PMCPMC7340672

What OpenQuestion 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 OpenQuestion graph.