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Non-small Cell Lung CancerPhase 1/2NCT02192697

An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

A Phase 1/2 study testing ASP8273 in people with Non-small Cell Lung Cancer, run by Astellas Pharma Inc at 14 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Purpose of the study is to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. the safety and tolerability of ASP8273. the pharmacokinetics (PK) of ASP8273. the antitumor activity of ASP8273. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-small Cell Lung Cancer
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
124 participants
Where
14 sitesin 3 countries
Study dates
23 Jan 2014to 14 Jun 2017
Phase
Phase 1/2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of NSCLC.
  • Patients confirmed to have the 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).
  • Life expectancy ≥ 12 weeks based on the investigator's/subinvestigator's judgment.
  • [Phase I]
  • Patients who have previously been treated with EGFR tyrosine-kinase inhibitors (EGFR-TKIs)*
  • Those who are not expected to show a therapeutic response to existing treatments in the investigator's/subinvestigator's opinion.
Show all 11Show fewer
  • [Phase II]
  • Patients who have been confirmed to have progressive disease (PD) after previous treatment with EGFR-TKIs*; for those who have received 2 or more regimens of previous treatment, the last regimen before enrollment should have included EGFR-TKIs.
  • *Erlotinib, gefitinib, and EGFR-TKIs under clinical investigation (e.g., neratinib, afatinib, dacomitinib)
  • Expression of the EGFR-T790M mutation as confirmed by a tumor biopsy of the primary or metastatic lesions after confirmation of PD following previous treatment with EGFR-TKIs and before enrollment, or by a tumor tissue sample that had been collected and archived after confirmation of PD following previous treatment with EGFR-TKIs.
  • At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Who cannot join

  • Persistent clinical evidence of previous antitumor treatment related toxicity ≥ Grade 2 using the Japan Clinical Oncology Group (JCOG) Japanese translation of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (NCI CTCAE v4.0 - JCOG) (except alopecia and skin toxicities considered irrelevant in study enrollment by the investigator/sub-investigator).
  • History of or concurrent interstitial lung disease
  • Received treatment with a reversible EGFR-TKI (erlotinib or gefitinib) within 8 days before the start of the study treatment.
  • Received previous treatment (except reversible EGFR-TKIs) intended to have antitumor effects or treatment with another investigational drug or an investigational device within 14 days before the start of the study treatment.
  • Previously received treatment with EGFR-TKIs (e.g., CO-1686, AZD9291) that can inhibit EGFR with the T790M mutation.
  • It is planned that the subject will undergo a surgical procedure during the course of the study or the subject still has an unhealed wound after previous surgery
  • Symptomatic central nervous system (CNS) lesions.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Japan9 sites

  • Site: 4

    Fukuoka

  • Site: 9

    Fukuoka

  • Site: 8

    Miyagi

  • Site: 7

    Okayama

  • Site: 3

    Osaka

  • Site: 6

    Osaka

  • Site: 2

    Shizuoka

  • Site: 1

    Tokyo

  • Site: 5

    Tokyo

Other trials in Japan

South Korea3 sites

  • Site: 10

    Seoul

  • Site: 11

    Seoul

  • Site: 12

    Seoul

Other trials in South Korea

Taiwan2 sites

  • Site: 13

    Taipei

  • Site: 14

    Taipei

Other trials in Taiwan

About this study

Official title: An Open-label Study of the Oral Administration of ASP8273 in Patients With Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

Purpose of the study is to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.

  • the safety and tolerability of ASP8273.
  • the pharmacokinetics (PK) of ASP8273.
  • the antitumor activity of ASP8273.
Read the detailed description

This study consists of Phase I and Phase II.

The objectives of Phase I are to determine the following in patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.

  • safety and tolerability of ASP8273.
  • the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ASP8273 based on the dose limiting toxicity (DLT) profile.
  • pharmacokinetics (PK) of ASP8273.
  • antitumor activity of ASP8273.

The objectives of Phase II are to determine the following at the RP2D of ASP8273 in patients with NSCLC harboring EGFR mutation.

  • efficacy of ASP8273
  • safety of ASP8273
  • PK of ASP8273
Being tested
ASP8273
Keywords
safety, pharmacokinetics, tolerability, ASP8273, Non-small Cell Lung Cancer, T790M resistance mutation, NSCLC, Epidermal Growth Factor Receptor mutations, irreversible EGFR inhibitor, antitumor activity, EGFR
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP8273Drug

    Oral administration

Study groups in NCT02192697
Study groupRoleWhat they receive
Phase I dose-escalation groupExperimentalOral administration
Receives: Drug: ASP8273
Phase I EGFR-T790M mutation groupExperimentalOral administration
Receives: Drug: ASP8273
Phase II groupExperimentalOral administration
Receives: Drug: ASP8273

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs)

    A DLT is defined as any pre-determined toxicity that is related to study drug per the investigator and which occurs during Cycle 0 and Cycle 1 using the Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver 4.0 - JCOG)

    Measured: Up to Day 23

  2. Phase II: Overall response rate (CR+PR) at Week 24

    The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated

    Measured: Week 24

Secondary outcomes (18)

  1. Phase I: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product

    Measured: Up to 18 months

  2. Phase I: Safety and tolerability of ASP8273 as assessed by laboratory tests

    Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation

    Measured: Up to 18 months

  3. Phase I: Safety and tolerability of ASP8273 as assessed by vital signs

    Vital signs to be measured includes blood pressure, pulse rate and temperature

    Measured: Up to 18 months

  4. Phase I: Safety and tolerability of ASP8273 as assessed by 12-lead ECG

    including the assessment of QT intervals

    Measured: Up to 18 months

  5. Phase I: Plasma concentrations of unchanged ASP8273

    Measured: Up to Day 1 of Cycle 3

  6. Phase I: Urine concentrations of unchanged ASP8273

    Measured: Up to Day 1 of Cycle 3

  7. Phase I: Overall response rate (CR+PR)

    The overall response rate is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated

    Measured: Up to 18 months

  8. Phase I: Disease control rate (CR+PR+SD)

    The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.

    Measured: Up to 18 months

  9. Phase II: Plasma concentrations of unchanged ASP8273

    Measured: Up to Day 1 of Cycle 3

  10. Phase II: Urine concentrations of unchanged ASP8273

    Measured: Up to Day 1 of Cycle 3

  11. Phase II: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product

    Measured: Up to 18 months

  12. Phase II: Safety and tolerability of ASP8273 as assessed by laboratory tests

    Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation

    Measured: Up to 18 months

  13. Phase II: Safety and tolerability of ASP8273 as assessed by vital signs

    Vital signs to be measured includes blood pressure, pulse rate and temperature

    Measured: Up to 18 months

  14. Phase II: Safety and tolerability of ASP8273 as assessed by 12-lead ECG

    including the assessment of QT intervals

    Measured: Up to 18 months

  15. Phase II: Disease control rate

    The disease control rate is defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) according to RECIST Version 1.1, will be calculated.

    Measured: Up to 18 months

  16. Phase II: Progression-free survival (PFS)

    Measured: Up to 18 months

  17. Phase II: Overall survival (OS)

    Measured: Up to 18 months

  18. Phase II: Overall response rate (CR+PR)

    The overall response rate, which is defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) according to RECIST Version 1.1, will be calculated

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2014 (estimated)
  2. Study start23 Jan 2014
  3. Primary completion15 Jan 2016
  4. Study completion14 Jun 2017

Why it stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02192697
Sponsor's protocol ID
8273-CL-0101
Status last verified
Nov 2024
First submitted
28 May 2014
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASP8273 in people with Non-small Cell Lung Cancer, run by Astellas Pharma Inc at 14 sites in 3 countries.

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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.). Results are not available in the source record.

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?

Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs) (time frame: Up to Day 23). 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?

On the ClinicalTrials.gov record for NCT02192697.

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 14 Nov 2024.

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