A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03042013|
Recruitment Status : Withdrawn (Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.)
First Posted : February 3, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Subjects With NSCLC With an EGFR Activating Mutation||Drug: ASP8273||Phase 2|
This is a multicenter, rollover study for subjects with non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) activating mutation who are currently participating in studies evaluating ASP8273.
Subjects should sign the informed consent at cycle 1 day 1 visit. The assessments from the last treatment visit from the parent study can be utilized for the cycle 1 day 1 visit. Either local or central laboratories may be utilized for the cycle 1 day 1 visit if assessments are used from the last treatment visit of the parent study. The subject will then receive ASP8273 study drug for the rollover study and return all ASP8273 study drug from the parent study. Subjects will continue on to subsequent 28-day cycles until 1 of the discontinuation criteria are met. Upon enrollment, subjects with fewer than 6 cycles of study drug dosing in the parent study will return to the clinic on day 1 of each cycle up to cycle 5. After cycle 5, these subjects can switch to day 1 of every other odd cycle for clinic visits. Subjects with 6 or more cycles of study drug dosing upon enrollment into the rollover study will return to the clinic on day 1 of every other odd cycle (e.g., cycles 3, 5, etc.). Imaging methods and frequency will be performed per standard of care.
An end of treatment study visit will be conducted 30 days after the last dose of study medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study|
|Actual Study Start Date :||February 28, 2017|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths)
- Incidence of adverse events (safety and tolerability) [ Time Frame: Up to a maximum of 1 month (per cycle) ]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
- Number of participants with laboratory value abnormalities and/or adverse events related to treatment [ Time Frame: Up to a maximum of 1 month (per cycle) ]Number of participants with potentially clinically significant laboratory values
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042013
|Study Director:||Senior Medical Director||Astellas Pharma Global Development, Inc.|