NCT02192697

An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

Terminated Phase 1, PHASE2 Last updated 14 November 2024

What this trial tests

Phase 1, PHASE2 trial testing ASP8273 in Non-small Cell Lung Cancer in 124 participants. Terminated before completion.

Timeline

23 January 2014

Primary endpoint
15 January 2016

14 June 2017

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	23 January 2014
Primary completion	15 January 2016
Estimated completion	14 June 2017
Sites	14 locations across Taiwan, Japan, South Korea

Drugs / interventions tested

• ASP8273 — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

20 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose of the study is to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.

* the safety and tolerability of ASP8273.
* the pharmacokinetics (PK) of ASP8273.
* the antitumor activity of ASP8273.

Publications & conference data

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

1. Tumor Heterogeneity and Lesion-Specific Response to Targeted Therapy in Colorectal Cancer.
   Russo M, Siravegna G, Blaszkowsky LS, Corti G, et al · · 2016 · cited 333× · PMID 26644315 · DOI 10.1158/2159-8290.cd-15-1283
2. Next-Generation <i>EGFR</i> Tyrosine Kinase Inhibitors for Treating <i>EGFR</i>-Mutant Lung Cancer beyond First Line.
   Sullivan I, Planchard D. · · 2016 · cited 67× · PMID 28149837 · DOI 10.3389/fmed.2016.00076
3. Update on recent preclinical and clinical studies of T790M mutant-specific irreversible epidermal growth factor receptor tyrosine kinase inhibitors.
   Liao BC, Lin CC, Lee JH, Yang JC. · · 2016 · cited 36× · PMID 27912760 · DOI 10.1186/s12929-016-0305-9
4. Genomic profiling toward precision medicine in non-small cell lung cancer: getting beyond EGFR.
   Richer AL, Friel JM, Carson VM, Inge LJ, et al · · 2015 · cited 27× · PMID 25897257 · DOI 10.2147/pgpm.s52845
5. Advances in clinical trials of targeted therapy and immunotherapy of lung cancer in 2018.
   Hu Z, Li M, Chen Z, Zhan C, et al · · 2019 · cited 25× · PMID 32010587 · DOI 10.21037/tlcr.2019.10.17
6. Novel approaches against epidermal growth factor receptor tyrosine kinase inhibitor resistance.
   Heydt C, Michels S, Thress KS, Bergner S, et al · · 2018 · cited 21× · PMID 29632655 · DOI 10.18632/oncotarget.24624
7. Development of epidermal growth factor receptor tyrosine kinase inhibitors against EGFR T790M. Mutation in non small-cell lung carcinoma.
   Wang Y, Guo Z, Li Y, Zhou Q. · · 2016 · cited 13× · PMID 28352770 · DOI 10.1515/med-2016-0014
8. Clinical activity of ASP8273 in Asian patients with non-small-cell lung cancer with EGFR activating and T790M mutations.
   Murakami H, Nokihara H, Hayashi H, Seto T, et al · · 2018 · cited 11× · PMID 29972716 · DOI 10.1111/cas.13724