Evidence map›Paper›PMID 25342141›Full record

ArticleInvestigational new drugs2015

Phase I dose-escalation study evaluating safety, tolerability and pharmacokinetics of MEDI-573, a dual IGF-I/II neutralizing antibody, in Japanese patients with advanced solid tumours.

Haruo Iguchi, Tomohiro Nishina, Naoyuki Nogami, Toshiyuki Kozuki, Yumiko Yamagiwa, Katsuro Yagawa

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

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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

6 authors.

Haruo IguchiClinical Research Center, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture, 791-0280, Japan, higuchi@shikoku-cc.go.jp.
Tomohiro Nishina
Naoyuki Nogami
Toshiyuki Kozuki
Yumiko Yamagiwa
Katsuro Yagawa

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis Phase I, open-label, single-arm, dose-escalation study aimed to evaluate the safety and tolerability of the insulin-like growth factor (IGF-I/II) neutralizing antibody, MEDI-573, in Japanese patients with advanced solid tumours refractory to standard therapy or for which no standard therapy exists. The pharmacokinetics, pharmacodynamics and antitumour activity of MEDI-573 were also evaluated.

methodsThree cohorts of patients received MEDI-573 in escalating order: cohort 1, 5 mg/kg on Day 1, 8 and 15; cohort 2, 15 mg/kg on Day 1, 8 and 15; cohort 3, 45 mg/kg on Day 1, of 21-day cycles.

resultsTen patients who received at least one dose of MEDI-573 were evaluated. The median number of treatment cycles was 2.0 (range 1-6) and the median number of MEDI-573 doses received was 4.0 (range 1-17). The most commonly reported drug-related adverse events were fatigue (n = 2 patients), pyrexia (n = 2), diarrhoea (n = 2) and electrocardiogram QT prolongation (n = 2). No patients experienced a dose-limiting toxicity. Pharmacokinetics of MEDI-573 were linear with a dose-dependent increase. There were no complete or partial responses; four patients had an overall best response of stable disease.

conclusionsMEDI-573 is well tolerated at the doses investigated.

Indexed as

Antibodies, NeutralizingAntineoplastic AgentsAgedAntibodies, Monoclonal, HumanizedAsian PeopleBroadly Neutralizing AntibodiesFemaleHumansInsulin-Like Growth Factor IInsulin-Like Growth Factor IIMaleMiddle AgedNeoplasmsTreatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntineoplastic AgentsBroadly Neutralizing AntibodiesdusigitumabInsulin-Like Growth Factor IInsulin-Like Growth Factor II

Identifiers

What OpenQuestion holds

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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.