Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment asp8273
Phase phase 1/phase 2
Targets EGFR, EGFR T790M mutation
Sponsor Astellas Pharma Inc
Start date January 2014
End date January 2016
Trial size 124 participants
Trial identifier NCT02192697, 8273-CL-0101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Oral administration
asp8273
Oral administration
(Experimental)
Oral administration
asp8273
Oral administration
(Experimental)
Oral administration
asp8273
Oral administration

Primary Outcomes

Measure
Phase I: Safety and tolerability of ASP8273 as assessed by Dose Limiting Toxicities (DLTs)
time frame: Up to Day 23
Phase II: Overall response rate (CR+PR) at Week 24
time frame: Week 24

Secondary Outcomes

Measure
Phase I: Safety and tolerability of ASP8273 as assessed by adverse events (AEs)
time frame: Up to 18 months
Phase I: Safety and tolerability of ASP8273 as assessed by laboratory tests
time frame: Up to 18 months
Phase I: Safety and tolerability of ASP8273 as assessed by vital signs
time frame: Up to 18 months
Phase I: Safety and tolerability of ASP8273 as assessed by 12-lead ECG
time frame: Up to 18 months
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
Phase I: Disease control rate (CR+PR+SD)
time frame: Up to 18 months
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
Phase II: Safety and tolerability of ASP8273 as assessed by laboratory tests
time frame: Up to 18 months
Phase II: Safety and tolerability of ASP8273 as assessed by vital signs
time frame: Up to 18 months
Phase II: Safety and tolerability of ASP8273 as assessed by 12-lead ECG
time frame: Up to 18 months
Phase II: Disease control rate
time frame: Up to 18 months
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

Eligibility Criteria

Male or female participants at least 20 years old.

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. - [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. - [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.

Additional Information

Official title Phase I and II Study of ASP8273 — 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 —
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.