Evidence map›Paper›PMID 25327557›Full record

ArticleOncotarget2014

A first in man phase I trial of the oral immunomodulator, indoximod, combined with docetaxel in patients with metastatic solid tumors.

Hatem H Soliman, Erica Jackson, Tony Neuger, E Claire Dees, R Donald Harvey, Hyo Han, Roohi Ismail-Khan, Susan Minton, Nicholas N Vahanian, Charles Link and 2 more

Open access · diamondAbstract readClinical Trial, Phase I
In one paragraph

Article in Oncotarget, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 1 pooled it
14.7field-weighted citation impact, top 1% 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

92 citing papers in PubMed, 1 synthesis or guideline pooled it, 170 citations in OpenAlex.

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32 more citing papers are in PubMed but not listed here.

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 5 institutions in 1 country.

Hatem H SolimanH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Erica JacksonUniversity of South Florida, Tampa, FL.
Tony NeugerH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
E Claire DeesUniversity of North Carolina/Lineberger Cancer Center, Chapel Hill, NC.
R Donald HarveyWinship Cancer Institute of Emory University, Atlanta, GA.
Hyo HanH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Roohi Ismail-KhanH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Susan MintonH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Nicholas N VahanianNewLink Genetics Inc, Ames, IA.
Charles LinkNewLink Genetics Inc, Ames, IA.
Daniel M SullivanH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Scott AntoniaH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Moffitt Cancer Center · USNewLink Genetics (United States) · USEmory University · USUNC Lineberger Comprehensive Cancer CenterUniversity of South Florida · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS HHSN261201100100CNCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundIndoleamine 2,3-dioxygenase (IDO) is an enzyme that tumors use to create a state of immunosuppression. Indoximod is an IDO pathway inhibitor. Preclinical studies demonstrated that indoximod combined with chemotherapy was synergistic in a mouse model of breast cancer. A phase I 3+3 trial was designed to study the combination of docetaxel and indoximod.

methodsDocetaxel was administered at 60 mg/m2 intravenously every 3 weeks dose levels 1-4 and 75 mg/m2 for dose level 5. Indoximod was given at 300, 600, 1000, 2000, and 1200 mg PO twice daily continuously for levels 1-5, respectively. Serum drug levels were measured.

resultsTwenty-seven patients were treated, with 22 evaluable for response. DLTs included grade 3 dehydration (level 1), hypotension(level 4), mucositis (level 4) and grade 5 enterocolitis (level 2). Dose level 5 is the recommended phase II dose. The most frequent adverse events were fatigue (58.6%), anemia (51.7%), hyperglycemia (48.3%), infection (44.8%), and nausea (41.4%). There were 4 partial responses (2 breast, 1 NSCLC, 1 thymic tumor). No drug-drug interactions were noted.

conclusionsDocetaxel plus indoximod was well tolerated with no increase in expected toxicities or pharmacokinetic interactions. It was active in a pretreated population of patients with metastatic solid tumors.

Indexed as

Administration, IntravenousAdministration, OralAdultAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDrug Administration ScheduleDrug MonitoringFemaleFloridaHumansImmunologic FactorsMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasms1-methyltryptophanDocetaxelImmunologic FactorsTaxoidsTryptophan

Identifiers

PMID25327557
PMCPMC4226672
OpenAlexW1502816311

What OpenQuestion holds

Textmetadata
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.