Evidence map›Paper›PMID 35731258›Full record

ArticleCancer chemotherapy and pharmacology2022

A phase Ib study of Oraxol (oral paclitaxel and encequidar) in patients with advanced malignancies.

Wen Wee Ma, Jenny J Li, Nilofer S Azad, Elaine T Lam, Jennifer R Diamond, Grace K Dy, Mateusz Opyrchal, Jay Zhi, Douglas Kramer, Wing-Kai Chan and 4 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2022. 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
0.6field-weighted citation impact, top 31% of its field
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, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
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

14 authors at 6 institutions in 1 country.

Wen Wee MaMayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Ma.WenWee@mayo.edu.ORCID 0000-0001-5899-4034
Jenny J LiMayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Nilofer S AzadThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, USA.
Elaine T LamUniversity of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Jennifer R DiamondUniversity of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Grace K DyRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Mateusz OpyrchalIndiana University, Indianapolis, IN, USA.
Jay ZhiAthenex Pharmaceuticals, Buffalo, NY, USA.
Douglas KramerAthenex Pharmaceuticals, Buffalo, NY, USA.
Wing-Kai ChanAthenex Pharmaceuticals, Buffalo, NY, USA.
David CutlerAthenex Pharmaceuticals, Buffalo, NY, USA.
Rudolf KwanAthenex Pharmaceuticals, Buffalo, NY, USA.
Alex A AdjeiMayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Antonio JimenoUniversity of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Athenex (United States) · USMayo Clinic · USUniversity of Colorado Anschutz Medical Campus · USIndiana University – Purdue University Indianapolis · USJohns Hopkins University · USRoswell Park Comprehensive Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOraxol is an oral formulation of paclitaxel administered with a novel, minimally absorbed P-glycoprotein inhibitor encequidar (HM30181A). This phase Ib study was conducted to determine the maximum-tolerated dose (MTD) of Oraxol administered at a fixed dose for up to 5 consecutive days in patients with advanced malignancies.

methodsPart 1 of this study utilized a 3 + 3 dose-escalation design to determine the MTD of oral paclitaxel 270 mg plus oral encequidar 15 mg administered daily. Dose escalation was achieved by increasing the number of consecutive dosing days per week (from 2 to 5 days per week). Dosing occurred for 3 consecutive weeks out of a 4-week cycle. Part 2 treated additional patients at the MTD to determine tolerability and recommended phase II dose (RP2D). Adverse events, tumor responses, and pharmacokinetic profiles were assessed.

resultsA total of 34 patients (n = 24 in Part 1, n = 10 in Part 2) received treatment. The MTD of Oraxol was determined to be 270 mg daily × 5 days per week per protocol definition and this was declared the RP2D. The most common treatment-related adverse events were fatigue, neutropenia, and nausea/vomiting. Hypersensitivity-type reactions were not observed. Of the 28 patients evaluable for response, 2 (7.1%) achieved partial response and 18 (64.3%) achieved stable disease. Pharmacokinetic analysis showed rapid absorption of paclitaxel when administered orally following encequidar. Paclitaxel daily exposure was comparable following 2-5 days dose levels.

conclusionThe oral administration of encequidar with paclitaxel was safe, achieved clinically relevant paclitaxel levels, and showed evidence of anti-tumor activity.

Indexed as

NeoplasmsPaclitaxelAdministration, OralAntineoplastic Combined Chemotherapy ProtocolsDose-Response Relationship, DrugFatigueHumansMaximum Tolerated DoseTreatment OutcomePaclitaxelOral paclitaxelOraxolPharmacokineticsPhase I

Identifiers

PMID35731258
OpenAlexW4283322276

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.