NCT02451956

Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy

Completed Phase 2 Last updated 30 December 2019

What this trial tests

Phase 2 trial testing AZD5363 in Advanced Gastric Cancer in 21 participants. Completed in 24 May 2019.

Timeline

7 January 2015

Primary endpoint
24 May 2019

24 May 2019

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	7 January 2015
Primary completion	24 May 2019
Estimated completion	24 May 2019
Sites	1 location across South Korea

Drugs / interventions tested

• AZD5363 (azd5363) — full drug profile →
• paclitaxel — full drug profile →

Conditions studied

• Advanced Gastric Cancer — all drugs for Advanced Gastric Cancer →

Sponsor

Samsung Medical Center

Who can join

20 and older, any sex, with Advanced Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single arm, single center phase II study of AZD5363 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or amplification as a second line chemotherapy.

Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed of 25 patients.

Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of enrollment, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Study treatment will be continued until objective disease progression.

Publications & conference data

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

1. Maximising the potential of AKT inhibitors as anti-cancer treatments.
   Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
2. Receptor tyrosine kinases and downstream pathways as druggable targets for cancer treatment: the current arsenal of inhibitors.
   Montor WR, Salas AROSE, Melo FHM. · · 2018 · cited 80× · PMID 29455659 · DOI 10.1186/s12943-018-0792-2
3. Genomic alterations in advanced gastric cancer endoscopic biopsy samples using targeted next-generation sequencing.
   Ge S, Li B, Li Y, Li Z, et al · · 2017 · cited 44× · PMID 28744403
4. The Relevance of Transcription Factors in Gastric and Colorectal Cancer Stem Cells Identification and Eradication.
   Pádua D, Figueira P, Ribeiro I, Almeida R, et al · · 2020 · cited 34× · PMID 32626705 · DOI 10.3389/fcell.2020.00442
5. New therapeutic options opened by the molecular classification of gastric cancer.
   Chivu-Economescu M, Matei L, Necula LG, Dragu DL, et al · · 2018 · cited 33× · PMID 29760539 · DOI 10.3748/wjg.v24.i18.1942
6. Immunometabolism in cancer: basic mechanisms and new targeting strategy.
   Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
7. Emerging Therapies in the Management of Advanced-Stage Gastric Cancer.
   Kumar V, Soni P, Garg M, Kamholz S, et al · · 2018 · cited 26× · PMID 30271341 · DOI 10.3389/fphar.2018.00404
8. Towards precision medicine: linking genetic and cellular heterogeneity in gastric cancer.
   Carrasco-Garcia E, García-Puga M, Arevalo S, Matheu A. · · 2018 · cited 18× · PMID 30181784 · DOI 10.1177/1758835918794628