Evidence map›Paper›PMID 31637669›Full record

ArticleInvestigational new drugs2020

Phase I study of intermittent olaparib capsule or tablet dosing in combination with carboplatin and paclitaxel (part 2).

Ruud van der Noll, Agnes Jager, Joo Ern Ang, Serena Marchetti, Marja W J Mergui-Roelvink, Johann S de Bono, Martijn P Lolkema, Maja J A de Jonge, Diane A van der Biessen, Andre T Brunetto and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00516724 (A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.6field-weighted citation impact, top 28% 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.

NCT00516724 phase1completednot on this map

A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours

TypeinterventionalSponsorAstraZenecaRan2007 to 2024Enrolled189ConditionsTriple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, PaclitaxelArmsKU-0059436 (AZD2281)(PARP inhibitor), Carboplatin, Paclitaxel, Paclitaxel + Carboplatin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. 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

15 authors at 7 institutions in 3 countries.

Ruud van der NollDepartment of Clinical Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. r.vd.noll@nki.nl.
Agnes JagerDepartment of Medical Oncology, Erasmus University MC Cancer Institute, PO Box 5201, 3008 AE, Rotterdam, The Netherlands.
Joo Ern AngThe Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK.
Serena MarchettiDepartment of Clinical Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Marja W J Mergui-RoelvinkDepartment of Clinical Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Johann S de BonoThe Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK.
Martijn P LolkemaDepartment of Medical Oncology, Erasmus University MC Cancer Institute, PO Box 5201, 3008 AE, Rotterdam, The Netherlands.
Maja J A de JongeDepartment of Medical Oncology, Erasmus University MC Cancer Institute, PO Box 5201, 3008 AE, Rotterdam, The Netherlands.
Diane A van der BiessenDepartment of Medical Oncology, Erasmus University MC Cancer Institute, PO Box 5201, 3008 AE, Rotterdam, The Netherlands.
Andre T BrunettoThe Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK.
Hendrik-Tobias ArkenauThe Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Downs Road, Sutton, Surrey, SM2 5PT, UK.
Ilian TchakovAstraZeneca, Alderley Park, Park Estate, Macclesfield, SK10 4TF, UK.
Jos H BeijnenDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Jacques De GrèveDepartment of Medical Oncology, Oncologisch Centrum UZ Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Jette, Belgium.
Jan H M SchellensDepartment of Clinical Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Erasmus MC Cancer Institute · NLInstitute of Cancer Research · GBThe Netherlands Cancer Institute · NLRoyal Marsden NHS Foundation Trust · GBUtrecht University · NLAstraZeneca (United Kingdom) · GBVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background In the first part of this extensive phase I study (NCT00516724), continuous olaparib twice daily (bid) with carboplatin and/or paclitaxel resulted in myelosuppression and dose modifications. Here, we report the safety, tolerability, and efficacy of intermittent olaparib dosing combined with carboplatin and paclitaxel. Methods Patients with advanced solid tumors (part D) and enriched for ovarian and breast cancer (part E) received olaparib (capsule and tablet formulations) using intermittent schedules (2 to 10 days of a 21-day cycle) combined with carboplatin/paclitaxel. Safety assessments included evaluation of dose-limiting toxicities (DLTs; cycle 1 only), adverse events (AEs), and physical examinations. Pharmacokinetic assessments of olaparib capsule and tablet combined with carboplatin/paclitaxel were performed. Tumor responses (RECIST) were assessed every 2 cycles. Results In total, 132 heavily pre-treated patients were included. One DLT of grade 3 elevated alanine aminotransferase lasting for 8 days was reported (olaparib tablet 100 mg bid days 3-12, carboplatin area under the curve 4 and paclitaxel 175 mg/m

Indexed as

AdultAgedAlopeciaAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCapsulesCarboplatinFatigueFemaleHumansMaleMiddle AgedNeoplasmsNeutropeniaPaclitaxelPhthalazinesAntineoplastic AgentsCapsulesCarboplatinolaparibPaclitaxelPhthalazinesPiperazinesTabletsCarboplatinOlaparibPaclitaxelPARP inhibitorPharmacokineticsPhase I

Identifiers

PMID31637669
OpenAlexW2981485667

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.