Evidence map›Paper›PMID 33744986›Full record

ArticleCancer chemotherapy and pharmacology2021

Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours.

Marit A C Vermunt, Lisa T van der Heijden, Jeroen J M A Hendrikx, Alfred H Schinkel, Vincent A de Weger, Eric van der Putten, Baukelien van Triest, Andries M Bergman, Jos H Beijnen

3 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 14% 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.

NCT01173913 phase1completednot on this map

Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2010 to 2017Enrolled57ConditionsCancerArmsModraDoc001 10mg capsules, ModraDoc003 10mg tablets and ModraDoc004 10/50 mg, ModraDoc006 10 mg tablet
NCT03066154 phase1terminatednot on this map

Weekly ModraDoc/r in Combination With Hormonal Treatment and High-dose Intensity-modulated Radiation Therapy in Patients With High-risk Early Stage Prostate Cancer

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2016 to 2022Enrolled24ConditionsProstatic NeoplasmsArmsoral docetaxel (ModraDoc/r), androgen deprivation therapy, high-dose intensity-modulated radiation therapy
NCT03136640 phase1completednot on this map

Multicenter Safety, Feasibility and Pharmacokinetic Phase I Trial of ModraDoc006/r in Patients With Metastatic Castration-resistant Prostate Cancer

TypeinterventionalSponsorModra PharmaceuticalsRan2017 to 2019Enrolled23ConditionsCastration-resistant Prostate CancerArmsModraDoc006/r
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
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

9 authors at 3 institutions in 1 country.

Marit A C VermuntDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands. m.vermunt@nki.nl.ORCID 0000-0002-2674-1291
Lisa T van der HeijdenDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Jeroen J M A HendrikxDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Alfred H SchinkelDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Vincent A de WegerDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Eric van der PuttenModra Pharmaceuticals BV, Barbara Strozzilaan 201, Amsterdam, 1083HN, The Netherlands.
Baukelien van TriestDepartment of Radiotherapy, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Andries M BergmanDepartment of Medical Oncology and Oncogenomics, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
Jos H BeijnenDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, Amsterdam, 1066CX, The Netherlands.
The Netherlands Cancer Institute · NLTeva Pharmaceuticals (Netherlands) · NLUtrecht University · NL

Funding

ZonMw 40-41200-98-004
6 · The paper itself

Abstract

purposeModraDoc006 is a novel oral formulation of docetaxel. The clearance of intravenous docetaxel is higher in medically castrated prostate cancer patients as compared to patients with other types of solid tumours. Oral docetaxel requires co-administration ritonavir (r), which might further impact the pharmacokinetics (PK). We now compare the PK of docetaxel and ritonavir between patients with Hormone Sensitive Prostate Cancer (HSPC), metastatic Castration-Resistant Prostate Cancer (mCRPC) and other metastatic solid tumours, treated on the same dose and weekly schedule of ModraDoc006/r.

methodsThe docetaxel and ritonavir PK were compared between four patient groups from three clinical phase I trials, including eight male and eight female patients with different types of solid tumours (study 1), seven patients with HSPC (study 2) and five patients with mCRPC (study 3). All patients were treated with ModraDoc006 30 mg and ritonavir 100 mg in the morning, followed by ModraDoc006 20 mg and ritonavir 100 mg in the evening (ModraDoc006/r 30-20/100-100). For comparative purposes, the PK of six mCRPC patients that received 30-20/200-100 in study 3 were also evaluated.

resultsThe maximum plasma concentration (C

conclusionThe exposure to docetaxel and ritonavir was significantly lower in prostate cancer patients as compared to patients with other types of solid tumours, treated on ModraDoc006/r 30-20/100-100. An increase of the ritonavir dose increased the docetaxel exposure in mCRPC patients. Therefore, a different RP2D of ModraDoc006/r is pursued in castrated prostate cancer patients as compared to patients with other types of solid tumours.

trial registrationStudy 1: ClinicalTrials.gov Identifier NCT01173913, date of registration August 2, 2010. Study 2: ClinicalTrials.gov Identifier NCT03066154, date of registration February 28, 2017. Study 3: ClinicalTrials.gov Identifier NCT03136640, date of registration May 2, 2017.

Indexed as

Administration, OralAgedAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDrug Administration ScheduleFemaleHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantRitonavirTreatment OutcomeDocetaxelRitonavirModraDoc006Oral docetaxelPharmacokineticsProstate cancerRitonavirSolid tumours

Identifiers

PMID33744986
OpenAlexW3137300049

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.