Evidence map›Paper›PMID 34980026›Full record

ArticleBMC cancer2022

A phase IA dose-escalation study of PHI-101, a new checkpoint kinase 2 inhibitor, for platinum-resistant recurrent ovarian cancer.

Soo Jin Park, Suk-Joon Chang, Dong Hoon Suh, Tae Wook Kong, Heekyoung Song, Tae Hun Kim, Jae-Weon Kim, Hee Seung Kim, Sung-Jong Lee

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04678102 (A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Pharmacokinetics of PHI-101 in Patients With Platinum-Resistance/Refractory Ovarian Cancer), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 8% 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.

NCT04678102 phase1unknown statusnot on this map

A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Pharmacokinetics of PHI-101 in Patients With Platinum-Resistance/Refractory Ovarian Cancer

TypeinterventionalSponsorSeoul National University HospitalRan2020 to 2023Enrolled36ConditionsPlatinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal CarcinomaArmsPHI-101 administration
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  3. Review
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  5. Article
  6. Cancer pharmacoinformatics: Databases and analytical tools.Functional & integrative genomics · 2024
    Review
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  8. Article
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  14. Immunotherapeutic Approaches in Ovarian Cancer.Current issues in molecular biology · 2023
    Review
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  17. 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 5 institutions in 5 countries.

Soo Jin ParkDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea.
Suk-Joon ChangGynecologic Cancer Center, Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Republic of Korea.
Dong Hoon SuhDepartment of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Tae Wook KongGynecologic Cancer Center, Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Republic of Korea.
Heekyoung SongDepartment of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero Seocho-gu, Seoul, 06591, Republic of Korea.
Tae Hun KimDepartment of Obstetrics and Gynecology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.
Jae-Weon KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea.
Hee Seung KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea. bboddi0311@snu.ac.kr.ORCID http://orcid.org/0000-0001-6876-8671
Sung-Jong LeeDepartment of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero Seocho-gu, Seoul, 06591, Republic of Korea. orlando@catholic.ac.kr.
Seoul National University · KRAjou University · KRSeoul National University Bundang Hospital · KRSt. Mary's Hospital · USThe Catholic University of Korea Seoul St. Mary's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPHI-101 is an orally available, selective checkpoint kinase 2 (Chk2) inhibitor. PHI-101 has shown anti-tumour activity in ovarian cancer cell lines and impaired DNA repair pathways in preclinical experiments. Furthermore, the in vivo study suggests the synergistic effect of PHI-101 through combination with PARP inhibitors for ovarian cancer treatment. The primary objective of this study is to evaluate the safety and tolerability of PHI-101 in platinum-resistant recurrent ovarian cancer.

methodsChk2 inhibitor for Recurrent EpitheliAl periToneal, fallopIan, or oVarian cancEr (CREATIVE) trial is a prospective, multi-centre, phase IA dose-escalation study. Six cohorts of dose levels are planned, and six to 36 patients are expected to be enrolled in this trial. Major inclusion criteria include ≥ 19 years with histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal cancer. Also, patients who showed disease progression during platinum-based chemotherapy or disease progression within 24 weeks from completion of platinum-based chemotherapy will be included, and prior chemotherapy lines of more than five will be excluded. The primary endpoint of this study is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of PHI-101. DISCUSSION: PHI-101 is the first orally available Chk2 inhibitor, expected to show effectiveness in treating recurrent ovarian cancer. Through this CREATIVE trial, DLT and MTD of this new targeted therapy can be confirmed to find the recommended dose for the phase II clinical trial. This study may contribute to developing a new combination regimen for the treatment of ovarian cancer.

trial registrationClinicalTrials.gov Identifier: NCT04678102 .

Indexed as

Antineoplastic Agents, ImmunologicalCheckpoint Kinase 2Immune Checkpoint InhibitorsNeoplasm Recurrence, LocalOvarian NeoplasmsAdultCarcinoma, Ovarian EpithelialDose-Response Relationship, DrugFallopian Tube NeoplasmsFemaleHumansMaximum Tolerated DoseMiddle AgedPeritoneal NeoplasmsPiperidinesProspective StudiesAntineoplastic Agents, ImmunologicalCheckpoint Kinase 2Immune Checkpoint InhibitorsPHI-101PiperidinesSulfur CompoundsChk2 inhibitorovarian cancerPARP inhibitorPhase IAPlatinum-resistance

Identifiers

PMID34980026
PMCPMC8722005
OpenAlexW4206052021

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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.