A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Pat… (NCT02500927) | Clinical Trial Compass
TerminatedPhase 2
A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR Mutations
Stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.
Japan31 participantsStarted 2015-06-25
Plain-language summary
The purpose of this study is to determine the safety, the antitumor activity and the pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
* Patients with a histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC.
* Patients confirmed to have the deletion of exon 19 (del ex19), L858R, G719X, or L861Q mutation among the EGFR activating mutations (patients at the study site who are documented to have any of the above-stated EGFR activating mutations can be enrolled in the study).
* Patients with a life expectancy ≥ 12 weeks based on the principal investigator's/subinvestigator's judgment.
* Patients who meet all of the following requirements for laboratory tests within 7 days before enrollment. When 2 or more test results for a single parameter are found within the specified period, the last data before enrollment should be used for assessment.
* Neutrophil count: ≥ 1,500/mm3
* Platelet count: ≥ 75,000/mm3
* Hemoglobin: ≥ 9 g/dL
* Serum creatinine: \< 1.5 mg/dL
* Total bilirubin (TBL): \< 1.5 × the upper limit of normal (ULN) at the site (this does not apply to patients with Gilbert syndrome)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): \< 2.5 ×the ULN at the site
* Patients who meet all the following requirements for prior treatment for NSCLC:
* Patients who have not received previous treatment with EGFR-TKIs\*1 \*1: Erlotinib, gefitinib, afatinib, and EGFR-TKIs under clinical investigation (e.g.,neratinib, dacomitinib). EGFR-TKIs that can inhibit E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety assessed by AEs
Timeframe: Up to 18 months
2
Safety assessed by Laboratory tests
Timeframe: Up to 18 months
3
Safety assessed by Vital signs
Timeframe: Up to 18 months
4
Safety assessed by Percutaneous oxygen saturation (SpO2)