A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Pa... | Not Recruiting
A Study of ASP8273 vs. Erlotinib or... | Not Recruiting
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
SOLAR

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Medical Conditions
  • Non-small Cell Lung Cancer (NSCLC)
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02588261
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of the study is to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

This study will also assess Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : naquotinib, Drug : Erlotinib, Drug : Gefitinib

Study Arm Groups : ASP8273, erlotinib/gefitinib, erlotinib/gefitinib

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival (PFS) as assessed by Independent Radiologic Review (IRR); Up to 36 months
Secondary Outcome Measures
    Overall Survival (OS); Up to 36 months; Best Overall Response Rate (ORR) as assessed by IRR; Up to 36 months; PFS as assessed by the investigator; Up to 36 months; Disease Control Rate (DCR) as assessed by IRR; Up to 36 months; Duration of Response (DOR) as assessed by IRR; Up to 36 months; Safety profile assessed by adverse events, laboratory tests, vital signs and electrocardiograms (ECG); Up to 36 months; Quality of Life (QoL) and patient-reported outcome (PRO) parameter as measured by FACT-EGFRI-18 questionnaire; Up to 36 months; Quality of Life (QoL) and patient-reported outcome (PRO) parameter as measured by EORTC-QLQ-LC13 questionnaire; Up to 36 months; Quality of Life (QoL) and patient-reported outcome (PRO) parameter as measured by EORTC-QLQ-C30 questionnaire; Up to 36 months; Quality of Life (QoL) and patient-reported outcome (PRO) parameter as measured by EQ-5D-5L questionnaire; Up to 36 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Subject agrees not to participate in another interventional study while on treatment.

    - Female subject must either:

    - Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile

    - Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; And have a negative serum pregnancy test at Screening; And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a highly effective method and one must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.

    - Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.

    - Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.

    - Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.

    - Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.

    - Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

    - Subject has histologically confirmed locally advanced, metastatic or unresectable Stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or recurrent). Subjects with mixed histology are eligible if adenocarcinoma is the predominant histology.

    - Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.

    - Subject must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.

    - Neutrophil count > 1,000/mm3

    - Platelet count ≥ 7.5 x 104 /mm3

    - Hemoglobin > 8.0 g/dL

    - Serum creatinine ˂ 2.0 x upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 mL/min as calculated by the Cockcroft Gault Method

    - Total bilirubin ˂1.5 x ULN (except for subjects with documented Gilbert's syndrome)

    - AST and ALT ˂ 3.0 x ULN or ≤ 5 x ULN if subject has documented liver metastases

    - Serum sodium level is ≥ 130 mmol/L

    - Subject has an EGFR activating mutation (exon 19 deletion or exon 21 L858R), with or without T790M mutation, by local or central testing on examination of a NSCLC FFPE specimen (archival or fresh biopsy). Subjects harboring both exon 19 deletion and exon 21 L858R mutations are not eligible. A tissue sample from the same block used to determine eligibility by local testing should be available to send to the central lab for confirmatory testing. Subjects randomized based on local results indicating presence of EGFR mutation may remain on study if central results are discordant.

    - Subject must have at least 1 measureable lesion based on RECIST V1.1. Previously irradiated lesions will not be considered as measurable lesions.

    Exclusion Criteria:

    - Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease other than palliative local radiation to painful bone metastases completed at least 1 week prior to the first dose of study drug. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ≥ 6 months before the first dose of study drug.

    - Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc).

    - Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.

    - Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.

    - Subject has symptomatic central nervous system (CNS) metastasis. Subject with previously treated brain or CNS metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy, does not have brain metastasis related symptoms, is not requiring systemic steroids for at least 2 weeks prior to study drug administration, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was completed at least 2 weeks prior to study drug administration. Steroid inhaler use or ointment treatment for other concomitant medical disease is permitted.

    - Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.

    - Subject has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study.

    - Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.

    - Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8273, erlotinib or gefitinib.

    - Subject has evidence of an active infection requiring systemic therapy within 14 days prior to the planned first dose of study drug.

    - Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure > 150/100 mmHg) or active bleeding diatheses.

    - Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.

    - Subject has ongoing cardiac arrhythmia that is Grade ≥ 2 or uncontrolled atrial fibrillation of any grade.

    - Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.

    - Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.

    - Subject has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the planned first dose of study drug.

    - Subject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).

    - Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.

    - Subject has another past or active malignancy which requires treatment. Prior carcinoma in situ or non-melanoma skin cancer after curative resection are permitted.

    - Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.

    - Subject has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sheffield
S10 2SJ
Mount Vernon Cancer Centre
HA6 2RN
University of Liverpool Clatterbridge Centre for Oncology
Wirral
CH63 4JY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, Chile, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Peru, Portugal, Romania, Russian Federation, Singapore, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
8273-CL-0302
Sponsor(s)
Astellas Pharma Global Development, Inc.
Key Dates

Recruitment Start Date

Feb 2016

Recruitment End Date

Nov 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

26 Oct 2015

Date updated in source

30 Oct 2017