Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010125

Trial Description

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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

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Trial Acronym

SOLAR

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URL of the Trial

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Brief Summary in Lay Language

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;
and Safety of ASP8273.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010125
  •   2016/06/09
  •   2015/10/26
  •   no
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Secondary IDs

  •   2015-002894-39 
  •   NCT02588261  (ClinicalTrials.gov)
  •   8273-CL-0302  (Astellas Pharma Global Development, Inc.)
  •   2015-002894-39 
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Health Condition or Problem studied

  •   Non-small Cell Lung Cancer (NSCLC)
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: ASP8273
  •   Drug: Erlotinib
  •   Drug: Gefitinib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Progression Free Survival (PFS) as assessed by Independent Radiologic Review (IRR); time frame: Up to 36 months; PFS is defined as the time from randomization to death from any cause or radiographic disease progression assessed according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1), whichever occurs first.

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Secondary Outcome

- Overall Survival (OS); time frame: Up to 36 months; OS is defined as the time from the date of randomization until the documented date of death from any cause.
- Best Overall Response Rate (ORR) as assessed by IRR; time frame: Up to 36 months; The ORR is defined as the proportion of subjects with a Complete Response (CR) or partial Response (PR) based on the RECIST V1.1.
- PFS as assessed by the investigator; time frame: Up to 36 months; PFS as assessed by the investigator is defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause.
- Disease Control Rate (DCR) as assessed by IRR; time frame: Up to 36 months; The DCR is defined as the proportion of subjects whose best overall response is rated as CR, PR or Stable Disease (SD) among all analyzed subjects.
- Safety profile assessed by adverse events, laboratory tests, vital signs and electrocardiograms (ECG; time frame: Up to 36 months; Laboratory Tests include hematology, biochemistry, urinalysis and coagulation. Vital signs include systolic and diastolic blood pressures, radial pulse rate and temperature.

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Countries of Recruitment

  •   Japan
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2015/11/30
  •   540
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 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. 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.

- Subject must have at least 1 measureable lesion based on RECIST V1.1.

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Exclusion Criteria

- Subject has received intervening anticancer treatment or previous treatment with
chemotherapy for metastatic disease. 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 and is not requiring escalating
doses of steroids, and any whole brain radiation therapy was completed at least 2
weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was
completed at least 1 week prior to the first dose of study drug.

- 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 malignancy which requires treatment.

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

- Subject has used the following drugs:

- Potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug

- Proton pump inhibitors such as omeprazole within 14 days prior to first dose of
study drug

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Addresses

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    • Astellas Pharma Global Development, Inc.
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    • Astellas Pharma Global Development, Inc.
    • Medical Monitor 
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    • Astellas Pharma Global Development 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
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  •   2016/02/25
* This entry means the parameter is not applicable or has not been set.