NCT03106155: [SUKSES-D]

Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Terminated Phase 2 Last updated 20 September 2018

What this trial tests

Phase 2 trial testing vistusertib (AZD2014) in Small Cell Lung Cancer in 4 participants. Terminated before completion.

Timeline

2 August 2017

Primary endpoint
3 May 2018

29 June 2018

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	2 August 2017
Primary completion	3 May 2018
Estimated completion	29 June 2018
Sites	1 location across South Korea

Drugs / interventions tested

• vistusertib (AZD2014)

Conditions studied

• Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →

Sponsor

Samsung Medical Center

Who can join

18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

\[Study Design\] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.

\[Primary Objective\] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the PI3K/AKT/mTOR Signaling Pathway in Lung Cancer: An Update Regarding Potential Drugs and Natural Products.
   Iksen, Pothongsrisit S, Pongrakhananon V. · · 2021 · cited 139× · PMID 34279440 · DOI 10.3390/molecules26134100
2. PTEN in Lung Cancer: Dealing with the Problem, Building on New Knowledge and Turning the Game Around.
   Gkountakos A, Sartori G, Falcone I, Piro G, et al · · 2019 · cited 83× · PMID 31404976 · DOI 10.3390/cancers11081141
3. Progression and metastasis of small cell lung carcinoma: the role of the PI3K/Akt/mTOR pathway and metabolic alterations.
   Krencz I, Sztankovics D, Danko T, Sebestyen A, et al · · 2021 · cited 30× · PMID 34958428 · DOI 10.1007/s10555-021-10012-4
4. Disruption of the RICTOR/mTORC2 complex enhances the response of head and neck squamous cell carcinoma cells to PI3K inhibition.
   Ruicci KM, Plantinga P, Pinto N, Khan MI, et al · · 2019 · cited 23× · PMID 31393061 · DOI 10.1002/1878-0261.12558
5. Small cell neuroendocrine carcinoma of the cervix: From molecular basis to therapeutic advances.
   Chao A, Wu RC, Lin CY, Chang TC, et al · · 2023 · cited 17× · PMID 37467967 · DOI 10.1016/j.bj.2023.100633
6. Rictor-A Mediator of Progression and Metastasis in Lung Cancer.
   Szalai F, Sztankovics D, Krencz I, Moldvai D, et al · · 2024 · cited 4× · PMID 38339294 · DOI 10.3390/cancers16030543
7. Strategies to Target Chemoradiotherapy Resistance in Small Cell Lung Cancer.
   Yu T, Lok BH. · · 2024 · PMID 39456533 · DOI 10.3390/cancers16203438