An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations
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ClinicalTrials.gov Identifier: NCT02192697 |
Recruitment Status :
Terminated
(Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.)
First Posted : July 17, 2014
Last Update Posted : October 17, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: ASP8273 | Phase 1 Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 124 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 23, 2014 |
Actual Primary Completion Date : | January 15, 2016 |
Actual Study Completion Date : | June 14, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase I dose-escalation group
Oral administration
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Drug: ASP8273
Oral administration |
Experimental: Phase I EGFR-T790M mutation group
Oral administration
|
Drug: ASP8273
Oral administration |
Experimental: Phase II group
Oral administration
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Drug: ASP8273
Oral administration |
- Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 23 ]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)
- Phase II: Overall response rate (CR+PR) at Week 24 [ Time Frame: 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
- Phase I: Safety and tolerability of ASP8273 as assessed by adverse events (AEs) [ Time Frame: Up to 18 months ]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
- Phase I: Safety and tolerability of ASP8273 as assessed by laboratory tests [ Time Frame: Up to 18 months ]Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation
- Phase I: Safety and tolerability of ASP8273 as assessed by vital signs [ Time Frame: Up to 18 months ]Vital signs to be measured includes blood pressure, pulse rate and temperature
- Phase I: Safety and tolerability of ASP8273 as assessed by 12-lead ECG [ Time Frame: Up to 18 months ]including the assessment of QT intervals
- Phase I: Plasma concentrations of unchanged ASP8273 [ Time Frame: Up to Day 1 of Cycle 3 ]
- Phase I: Urine concentrations of unchanged ASP8273 [ Time Frame: Up to Day 1 of Cycle 3 ]
- Phase I: Overall response rate (CR+PR) [ Time Frame: Up to 18 months ]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
- Phase I: Disease control rate (CR+PR+SD) [ Time Frame: Up to 18 months ]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.
- Phase II: Plasma concentrations of unchanged ASP8273 [ Time Frame: Up to Day 1 of Cycle 3 ]
- Phase II: Urine concentrations of unchanged ASP8273 [ Time Frame: Up to Day 1 of Cycle 3 ]
- Phase II: Safety and tolerability of ASP8273 as assessed by adverse events (AEs) [ Time Frame: Up to 18 months ]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
- Phase II: Safety and tolerability of ASP8273 as assessed by laboratory tests [ Time Frame: Up to 18 months ]Laboratory tests to be conducted are hematology, biochemistry, urinalysis, coagulation profile, lipid panel and lymphocyte subpopulation
- Phase II: Safety and tolerability of ASP8273 as assessed by vital signs [ Time Frame: Up to 18 months ]Vital signs to be measured includes blood pressure, pulse rate and temperature
- Phase II: Safety and tolerability of ASP8273 as assessed by 12-lead ECG [ Time Frame: Up to 18 months ]including the assessment of QT intervals
- Phase II: Disease control rate [ Time Frame: Up to 18 months ]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.
- Phase II: Progression-free survival (PFS) [ Time Frame: Up to 18 months ]
- Phase II: Overall survival (OS) [ Time Frame: Up to 18 months ]
- Phase II: Overall response rate (CR+PR) [ Time Frame: Up to 18 months ]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

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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[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.
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[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.
Exclusion Criteria:
- 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.

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): NCT02192697
Japan | |
Site: 4 | |
Fukuoka, Japan | |
Site: 9 | |
Fukuoka, Japan | |
Site: 8 | |
Miyagi, Japan | |
Site: 7 | |
Okayama, Japan | |
Site: 3 | |
Osaka, Japan | |
Site: 6 | |
Osaka, Japan | |
Site: 2 | |
Shizuoka, Japan | |
Site: 1 | |
Tokyo, Japan | |
Site: 5 | |
Tokyo, Japan | |
Korea, Republic of | |
Site: 10 | |
Seoul, Korea, Republic of | |
Site: 11 | |
Seoul, Korea, Republic of | |
Site: 12 | |
Seoul, Korea, Republic of | |
Taiwan | |
Site: 13 | |
Taipei, Taiwan | |
Site: 14 | |
Taipei, Taiwan |
Study Director: | Medical Director | Astellas Pharma Inc |
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT02192697 |
Other Study ID Numbers: |
8273-CL-0101 |
First Posted: | July 17, 2014 Key Record Dates |
Last Update Posted: | October 17, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data. |
Access Criteria: | Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement. |
URL: | https://www.clinicalstudydatarequest.com/ |
safety pharmacokinetics tolerability ASP8273 Non-small Cell Lung Cancer T790M resistance mutation |
NSCLC Epidermal Growth Factor Receptor mutations irreversible EGFR inhibitor antitumor activity EGFR |
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