Evidence map›Paper›PMID 23975329›Full record

Trial reportCancer chemotherapy and pharmacology2013

A phase I/II study of carfilzomib 2-10-min infusion in patients with advanced solid tumors.

Kyriakos P Papadopoulos, Howard A Burris, Michael Gordon, Peter Lee, Edward A Sausville, Peter J Rosen, Amita Patnaik, Richard E Cutler, Zhengping Wang, Susan Lee and 2 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 3% 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

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.

  1. Pooled it
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  7. Review
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  9. Review
  10. Article
  11. Size optimization of carfilzomib nanocrystals for systemic delivery to solid tumors.Journal of controlled release : official journal of the Controlled Release Society · 2022
    Article
  12. Article
  13. Research progress in proteasome inhibitor resistance to multiple myeloma.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2021
    Article
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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

12 authors at 8 institutions in 1 country.

Kyriakos P PapadopoulosSouth Texas Accelerated Research Therapeutics (START), 4383 Medical Dr, Room 4042, San Antonio, TX, 78229, USA, kyri.papadopoulos@start.stoh.com.
Howard A Burris
Michael Gordon
Peter Lee
Edward A Sausville
Peter J Rosen
Amita Patnaik
Richard E Cutler
Zhengping Wang
Susan Lee
Suzanne F Jones
Jeffery R Infante
South Texas Accelerated Research Therapeutics · USTennessee Oncology · USPinnacle Oncology Hematology · USProvidence Saint Joseph Medical Center · USSarah Cannon · USSunesis (United States) · USTower Cancer Research Foundation · USUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of carfilzomib, a selective proteasome inhibitor, administered twice weekly by 2-10-min intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 in 28-day cycles, were assessed in patients with advanced solid tumors in this phase I/II study.

methodsAdult patients with solid tumors progressing after ≥1 prior therapies were enrolled. The dose was 20 mg/m(2) in week 1 of cycle 1 and 20, 27, or 36 mg/m(2) thereafter. The maximum tolerated dose or protocol-defined maximum planned dose (MPD) identified during dose escalation was administered to an expansion cohort and to patients with small cell lung, non-small cell lung, ovarian, and renal cancer in phase II tumor-specific cohorts.

resultsFourteen patients received carfilzomib during dose escalation. The single dose-limiting toxicity at 20/36 mg/m(2) was grade 3 fatigue, establishing the MPD as the expansion and phase II dose. Sixty-five additional patients received carfilzomib at the MPD. Adverse events included fatigue, nausea, anorexia, and dyspnea. Carfilzomib PK was dose proportional with a half-life <1 h. All doses resulted in at least 80 % proteasome inhibition in blood. Partial responses occurred in two patients in phase I, with 21.5 % stable disease after four cycles in evaluable patients in the expansion and phase II cohorts.

conclusionCarfilzomib 20/36 mg/m(2) was well tolerated when administered twice weekly by 2-10-min IV infusion. At this dose and infusion rate, carfilzomib inhibited the proteasome in blood but demonstrated limited antitumor activity in patients with advanced solid tumors.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDose-Response Relationship, DrugFemaleHalf-LifeHumansInfusions, IntravenousMaleMaximum Tolerated DoseMiddle AgedNeoplasmsOligopeptidesProteasome Endopeptidase ComplexProteasome InhibitorsAntineoplastic AgentscarfilzomibOligopeptidesProteasome Endopeptidase ComplexProteasome Inhibitors

Identifiers

PMID23975329
PMCPMC3784064
OpenAlexW2087157354

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.