Subjects With NSCLC With an EGFR Activating MutationPhase 2NCT03042013
A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
A Phase 2 study testing ASP8273 in people with Subjects With NSCLC With an EGFR Activating Mutation, run by Astellas Pharma Global Development, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With NSCLC With an EGFR Activating Mutation
- What is being tested?
- ASP8273
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2017to 28 Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
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.
Read the detailed description
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.
- Being tested
- ASP8273
- Keywords
- ASP8273, Non-Small-Cell Lung Cancer, EGFR mutations, Oncology
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8273Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP8273 | Experimental | Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths) Receives: Drug: ASP8273 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (safety and tolerability)
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
Measured: Up to a maximum of 1 month (per cycle)
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Number of participants with potentially clinically significant laboratory values
Measured: Up to a maximum of 1 month (per cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start28 Feb 2017
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Why it stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With NSCLC With an EGFR Activating MutationStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042013
- Sponsor's protocol ID
- 8273-CL-0201
- Other IDs
- 2016-003183-39, 2016
- Status last verified
- Jul 2017
- First submitted
- 1 Feb 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
- ClinicalTrials.gov ID
- NCT03042013
- Acronym / sponsor ID
- 8273-CL-0201
- Keywords
- ASP8273, Non-Small-Cell Lung Cancer, EGFR mutations, Oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP8273 | Experimental | Drug: ASP8273Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- Subject has any condition which may require treatment during the study and may make the subject unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8273Oral | Drug | ASP8273 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: Undecided
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NSCLC Stage IIIB, NSCLC Stage IIIC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP8273 in people with Subjects With NSCLC With an EGFR Activating Mutation, run by Astellas Pharma Global Development, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (safety and tolerability) (time frame: Up to a maximum of 1 month (per cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.