Evidence map›Paper›PMID 22143378›Full record

ArticleCancer chemotherapy and pharmacology2012

Phase I study for ridaforolimus, an oral mTOR inhibitor, in Japanese patients with advanced solid tumors.

Yoshitaka Seki, Noboru Yamamoto, Yosuke Tamura, Yasushi Goto, Takashi Shibata, Maki Tanioka, Hajime Asahina, Hiroshi Nokihara, Yasuhide Yamada, Takashi Shimamoto and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00694083 (A Phase I Study of MK-8669 in Patients With Metastatic or Locally Advanced Solid Tumors), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 19% 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.

NCT00694083 phase1completednot on this map

A Phase I Study of MK-8669 in Patients With Metastatic or Locally Advanced Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2009Enrolled13ConditionsNeoplasmArmsRidaforolimus
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
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  10. The Biological Role of PI3K Pathway in Lung Cancer.Pharmaceuticals (Basel, Switzerland) · 2012
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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 2 institutions in 2 countries.

Yoshitaka SekiDivision of Internal Medicine, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
Noboru Yamamoto
Yosuke Tamura
Yasushi Goto
Takashi Shibata
Maki Tanioka
Hajime Asahina
Hiroshi Nokihara
Yasuhide Yamada
Takashi Shimamoto
Kazuo Noguchi
Tomohide Tamura
National Cancer Center · USMSD K.K. (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRidaforolimus is a non-prodrug mTOR inhibitor. The safety, pharmacokinetics (PK), and antitumor activity of oral ridaforolimus were assessed in Japanese patients with refractory solid tumors.

methodsRidaforolimus (20 or 40 mg) was administered as a single dose on Day 1, followed by once daily dosing five times a week for a 3-week cycle beginning on Day 8. Full PK sampling was performed on Days 1 and 26.

resultsThirteen patients (7 at 20 mg and 6 at 40 mg) were enrolled. The median treatment duration was 82 days. The most common drug-related adverse events were stomatitis, hypertriglyceridemia, and proteinuria. Two patients had dose-limiting toxicities (grade 3 stomatitis at 20 mg, and grade 3 anorexia and vomiting at 40 mg). Four patients had grade 1 interstitial pneumonitis. Ridaforolimus in the whole blood was rapidly absorbed and slowly eliminated with a half-life of approximately 56-58 h after a single dose. Two patients (with non-small cell lung cancer and angiosarcoma, respectively) achieved a partial response, and five patients (one with thymic cancer and four with soft tissue sarcomas) had a stable disease for ≥ 16 weeks.

conclusionsRidaforolimus was well tolerated up to a dose of 40 mg in Japanese patients. Preliminary evidence of antitumor activity was observed for patients with solid tumors. Further investigation at this dose is warranted.

Indexed as

AdultAgedDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansJapanMaleMiddle AgedNeoplasmsProtein Kinase InhibitorsSirolimusTOR Serine-Threonine KinasesMTOR protein, humanProtein Kinase InhibitorsridaforolimusSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID22143378
PMCPMC3313018
OpenAlexW2004907451

What OpenQuestion holds

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Registered trials

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.