JRCT ID: jRCTs051180183
Registered date:26/03/2019
A phase I study of osimertinib with bevacizumab and randomized phase II study of osimertinib with or without bevacizumab in EGFR mutated, T790M positive patients who had progressed EGFR-TKIs. (WJOG8715L)
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | Lung Cancer |
Date of first enrollment | 10/02/2017 |
Target sample size | 86 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Arm A: Osimertinib 80mg/day, orally every day until disease progression Arm A: Osimertinib 80mg/day, orally every day until disease progression plus bevacizumab 15mg/kg, intravenously every 3 weeks, until disease progression |
Outcome(s)
Primary Outcome | Phase I: safety Phase II: progression-free survival |
---|---|
Secondary Outcome | Overall response rate, time to treatment failure, survival time |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Pathologically proven, advanced lung adenocarcinoma 2. Harbor with EGFR mutation 3. Radiological progression was confirmed after 1st/2nd EGFR-TKI, and T790M was confirmed. 4. With evaluable lesion per RECIST ver 1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 |
Exclude criteria | 1. Subjects with interstitial lung disease 2. Subjects with high risk of bleeding 3. Positive test for hepatitis B virus antigen |
Related Information
Primary Sponsor | Teraoka Shunsuke |
---|---|
Secondary Sponsor | Akamatsu Hiroaki |
Source(s) of Monetary Support | AstraZeneca K.K. |
Secondary ID(s) | UMIN000023761 |
Contact
Public contact | |
Name | Shunsuke Teraoka |
Address | 811-1, kimiidera, wakayama city Wakayama Japan 6418509 |
Telephone | +81-734410619 |
teraoka@wakayama-med.ac.jp | |
Affiliation | Wakayama medical university hospital |
Scientific contact | |
Name | Shunsuke Teraoka |
Address | 811-1, kimiidera, wakayama city Wakayama Japan 6418509 |
Telephone | +81-734410619 |
teraoka@wakayama-med.ac.jp | |
Affiliation | Wakayama medical university hospital |