Evidence map›Paper›PMID 37036671›Full record

Trial reportThe oncologist2023

AZD8186 in Combination With Paclitaxel in Patients With Advanced Gastric Cancer: Results From a Phase Ib/II Study (KCSG ST18-20).

Koung Jin Suh, Min-Hee Ryu, Dae Young Zang, Woo Kyun Bae, Hye Seung Lee, Hyeon Jeong Oh, Minsu Kang, Ji-Won Kim, Bum Jun Kim, Peter G S Mortimer and 2 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04001569 (Phase1b/2 Study of AZD8186 in Combination With Paclitaxel in Patients With Advanced Gastric Cancer), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.8field-weighted citation impact, top 10% 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.

NCT04001569 phase1 / phase2unknown statusnot on this map

Phase1b/2 Study of AZD8186 in Combination With Paclitaxel in Patients With Advanced Gastric Cancer

TypeinterventionalSponsorSeoul National University Bundang HospitalRan2019 to 2022Enrolled49ConditionsSolid Tumor, Stomach CancerArmsAZD8186 in combination with paclitaxel
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 2 countries.

Koung Jin SuhDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Republic of Korea.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Dae Young ZangDivision of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Gyeonggi-do, Republic of Korea.
Woo Kyun BaeDepartment of Internal Medicine, Chonnam National University Medical School, Gwangju, Republic of Korea.
Hye Seung LeeDepartment of Pathology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Hyeon Jeong OhDepartment of Pathology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Republic of Korea.
Minsu KangDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Republic of Korea.
Ji-Won KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Republic of Korea.
Bum Jun KimDivision of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Gyeonggi-do, Republic of Korea.
Peter G S MortimerOncology R&D, AstraZeneca, Cambridge, UK.
Hee Jung KimOncology R&D, AstraZeneca, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Republic of Korea.ORCID 0000-0002-8491-703X
Seoul National University Bundang Hospital · KRHallym University Medical Center · KRAstraZeneca (South Korea) · KRAstraZeneca (United Kingdom) · GBChonnam National University · KRSeoul National University Hospital · KRUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLoss of PTEN function leads to increased PI3Kβ signaling. AZD8186, a selective PI3Kβ/δ inhibitor, has shown anti-tumor activity in PTEN-deficient preclinical models. Although the combination of AZD8186 and paclitaxel was well tolerated, limited clinical efficacy was observed in advanced gastric cancer with PTEN loss.

methodsIn the phase Ib dose-escalation, subjects with advanced solid tumors received oral AZD8186 (60 mg or 120 mg; twice daily (BID); 5 days on/2 days off) plus intravenous paclitaxel (70 mg/m2 or 80 mg/m2; days 1, 8, and 15) every 4 weeks. In the phase II part, MRGC patients with PTEN loss or PTEN/PIK3CB gene abnormality were enrolled and received recommended phase II dose (RP2D) of AZD8186 plus paclitaxel. Primary endpoints were to determine maximum tolerated dose (MTD) and RP2D in phase Ib and 4-month progression-free survival (PFS) rate in phase II.

resultsIn phase Ib, both MTD and RP2D were determined at paclitaxel 80 mg/m2 and AZD8186 120 mg BID. In phase II, 18 patients were enrolled [PTEN loss (n = 18) and PIK3CB mutation (n = 1)]. The 4-month PFS rate was 18.8% (3 of 16 evaluable patients) and further enrollment stopped due to futility.

conclusionAlthough the combination of AZD8186 and paclitaxel was well tolerated, limited clinical efficacy was observed.ClinicalTrials.gov Identifier: NCT04001569.

Indexed as

PaclitaxelStomach NeoplasmsAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsChromonesHumansMaximum Tolerated DoseRepressor ProteinsAniline CompoundsAZD8186ChromonesPaclitaxelRepressor ProteinsST18 protein, humanAZD8186gastric cancerpaclitaxelPI3KPIK3CBPTEN

Identifiers

PMID37036671
PMCPMC10485284
OpenAlexW4363625980

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.