Evidence map›Paper›PMID 25344453›Full record

Trial reportInvestigational new drugs2015

Phase I/II study with ruthenium compound NAMI-A and gemcitabine in patients with non-small cell lung cancer after first line therapy.

Suzanne Leijen, Sjaak A Burgers, Paul Baas, Dick Pluim, Matthijs Tibben, Erik van Werkhoven, Enzo Alessio, Gianni Sava, Jos H Beijnen, Jan H M Schellens

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report 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 110 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 1 pooled it
–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

110 citing papers in PubMed, 1 synthesis or guideline pooled it.

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50 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

10 authors.

Suzanne LeijenDepartment of Clinical Pharmacology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Sjaak A Burgers
Paul Baas
Dick Pluim
Matthijs Tibben
Erik van Werkhoven
Enzo Alessio
Gianni Sava
Jos H Beijnen
Jan H M Schellens

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase I/II study determined the maximal tolerable dose, dose limiting toxicities, antitumor activity, the pharmacokinetics and pharmacodynamics of ruthenium compound NAMI-A in combination with gemcitabine in Non-Small Cell Lung Cancer patients after first line treatment.

methodsInitial dose escalation of NAMI-A was performed in a 28 day cycle: NAMI-A as a 3 h infusion through a port-a-cath at a starting dose of 300 mg/m(2) at day 1, 8 and 15, in combination with gemcitabine 1,000 mg/m(2) at days 2, 9 and 16. Subsequently, dose escalation of NAMI-A in a 21 day schedule was explored. At the maximal tolerable dose level of this schedule an expansion group was enrolled of which 15 patients were evaluable for response.

resultsDue to frequent neutropenic dose interruptions in the third week, the 28 day schedule was amended into a 21 day schedule. The maximal tolerable dose was 300 and 450 mg/m(2) of NAMI-A (21 day schedule). Main adverse events consisted of neutropenia, anemia, elevated liver enzymes, transient creatinine elevation, nausea, vomiting, constipation, diarrhea, fatigue, and renal toxicity.

conclusionNAMI-A administered in combination with gemcitabine is only moderately tolerated and less active in NSCLC patients after first line treatment than gemcitabine alone.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDeoxycytidineDimethyl SulfoxideFemaleGemcitabineHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedOrganometallic CompoundsRutheniumRuthenium CompoundsDeoxycytidineDimethyl SulfoxideGemcitabineimidazolium-bis(imidazole)dimethylsulfoxideimidazotetrachlororuthenate(III)Organometallic CompoundsRutheniumRuthenium Compounds

Identifiers

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.