Trial reportThe Indian journal of medical research2021
A randomized, double-blind, parallel-group, single-dose comparative pharmacokinetic study of DRL_TZ, a candidate biosimilar of trastuzumab, with Herceptin
Trial report in The Indian journal of medical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed, 2 citations in OpenAlex.
- Efficacy, Safety, Pharmacokinetics, and Immunogenicity of DRL-Trastuzumab Versus Herceptin in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Randomized Controlled Trial.JCO global oncology · 2024Trial
- Monoclonal antibody biosimilars for cancer treatment.iScience · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
objectivesTrastuzumab (TZ) is a recombinant DNA-derived humanized monoclonal antibody approved for human epidermal growth factor receptor 2 positive early breast cancer, metastatic breast and gastric cancers. For the development of TZ biosimilars, establishing pharmacokinetic equivalence is required. The primary objective of this study was to compare the pharmacokinetics (PK) of Dr Reddy's Laboratories TZ (DRL_TZ) with that of EU-approved Reference Medicinal Product (RMP), Herceptin
methodsIn this double-blind, parallel-group, phase I study (TZ-01-003), healthy male subjects aged 18-55 yr were randomized 1:1 to receive a single intravenous infusion of 6 mg/kg of TZ as DRL_TZ or RMP. Similarity for primary PK parameters was defined as the 90 per cent confidence intervals (CIs) for the geometric mean ratios (GMRs) falling within 75-133 per cent limits. Primary endpoints included area under the concentration-time curve - from time zero (pre-dose) to the last quantifiable concentration [AUC
resultsThirty two subjects were dosed (DRL_TZ, 16; RMP, 16). Primary PK parameters were found to be comparable with their 90 per cent CIs for the GMR falling within the usual more stringent limits of 80-125 per cent. The number of subjects reporting at least one TEAE in both the arms was similar. No serious adverse events were reported. Fifteen subjects, eight in DRL_TZ arm and seven in Herceptin INTERPRETATION &
conclusionsIn this study, DRL_TZ demonstrated PK equivalence with the RMP and had comparable safety and immunogenicity profiles in healthy adult male subjects.
Indexed as
Identifiers
What OpenQuestion holds
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.