Clinical trial · Interventional
A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.
Summary
Brief summary (as posted)
The purpose of the study is to evaluate long-term safety and tolerability of continuous treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273 study which has completed, at a minimum, the primary analysis or have completed the individual study evaluation period and for whom the investigator feels the subject may have potential to continue to derive clinical benefit from treatment with ASP8273.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Subjects With NSCLC With an EGFR Activating Mutation | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASP8273 | Drug | Naquotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASP8273
- description
- Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths)
- interventionNames
- Drug: ASP8273
Primary outcomes (2)
- measure
- Incidence of adverse events (safety and tolerability)
- timeFrame
- Up to a maximum of 1 month (per cycle)
- description
- An Adverse Event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product
- measure
- Number of participants with laboratory value abnormalities and/or adverse events related to treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be participating in an Astellas-sponsored ASP8273 study which has completed, at a minimum, the primary analysis or have completed the individual study evaluation period requirements. Subject must not have met any discontinuation criteria in the parent study. * Subject must be receiving a stable dose of ASP8273 for 14 days minimum and is able to enroll into this rollover study without treatment interruption of study drug, or with no more than 21 consecutive days of treatment interruption in study drug within the parent study. * Subject should be deriving clinical benefit without any persistent intolerable toxicity from continued treatment of ASP8273. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject who developed persistent intolerable toxicity to ASP8273 treatment in the parent study. * Subject who received any other systemic anticancer treatment after parent study entry (radiation to local areas such as bone or brain if received in the parent ASP8273 study is permitted). * Subject who requires the following medications will be excluded: * Chemotherapy, radiotherapy, immunotherapy or other medications intended for antitumor activity * Investigational products or therapy other than ASP8273 * Strong inhibitors or inducers of CYP3A4 * Permeability-glycoprotein (P-gp) substrates with a narrow therapeutic index * Subject has any condition which may require treatment during the study and may make the subject unsuitable for study participation.
References
Publications (0)
Data not yet available