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Trial record 10 of 197 for:    "Virginia Cancer Specialists" | United States

A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

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ClinicalTrials.gov Identifier: NCT03082300
Recruitment Status : Terminated (Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.)
First Posted : March 17, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The objective of this study is to evaluate the bioequivalence of a tablet formulation versus a capsule formulation of ASP8273 following a single dose under fasted condition in subjects with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. The study will also evaluate the safety and tolerability of a tablet formulation as a single dose and a capsule formulation as a single and multiple dose of ASP8273 in subjects with NSCLC harboring EGFR mutations.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Epidermal Growth Factor Receptor (EGFR) Mutations Drug: naquotinib Phase 1

Detailed Description:
Study and subjects will be divided into two phases: a pharmacokinetic (PK) and a postpharmacokinetic phase. The pharmacokinetic phase will follow a randomized, 2 period, 2 sequence single dose crossover design. Each period will be 5 days in duration. Within the sequence, both an ASP8273 tablet and ASP8273 capsule will be administered under fasted condition. The postpharmacokinetic phase will consist of up to 1 cycle (28 days) of continuous once daily dosing in post PK phase with ASP8273 capsules. Dose modifications are allowed if necessary in post PK phase and they follow a step-wise dose reduction. Subject is able to re-escalate dose level if reaction is stable.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, 2-period Crossover Study to Assess Bioequivalence of a Tablet Formulation Versus a Capsule Formulation of ASP8273 in Subjects With Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : May 12, 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Urogastrone

Arm Intervention/treatment
Experimental: Pharmacokinetic phase: ASP8273 Tablet then Capsule Sequence
Subjects will receive a single oral dose in tablet formulation on Day 1 of period 1 under fasted condition, then subjects will receive a single oral dose of ASP8273 in capsule formulation on Day 1 of period 2 under fasted condition. Each period will be for 5 days
Drug: naquotinib
Oral
Other Name: ASP8273

Experimental: Pharmacokinetic phase: ASP8273 Capsule then Tablet Sequence
Subjects will receive a single oral dose in capsule formulation on Day 1 of period 1 under fasted condition, then subjects will receive a single oral dose of ASP8273 in tablet formulation on Day 1 of period 2 under fasted condition. Each period will be for 5 days
Drug: naquotinib
Oral
Other Name: ASP8273

Experimental: Postpharmacokinetic phase: ASP8273 Capsule Formulation
All subjects will receive ASP8273 capsules in once-daily dosing for 1 cycle (28 days)
Drug: naquotinib
Oral
Other Name: ASP8273




Primary Outcome Measures :
  1. Pharmacokinetics of ASP8273 in plasma: Cmax [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    Cmax: Maximum plasma concentration. Pharmacokinetic phase only

  2. Pharmacokinetics of ASP8273 in plasma: AUCinf [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    AUCinf: Area under the concentration time curve extrapolated to time infinity. Pharmacokinetic phase only

  3. Pharmacokinetics of ASP8273 in plasma: AUClast [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    AUClast: Area under the concentration time curve from time zero to the last quantifiable concentration. Pharmacokinetic phase only

  4. Pharmacokinetics of ASP8273 in plasma: AUC72 [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    AUC72: Area under the concentration time curve truncated at 72 hours. Pharmacokinetic phase only


Secondary Outcome Measures :
  1. Pharmacokinetics of ASP8273 in plasma: t1/2 [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    t1/2: Terminal elimination half-life. Pharmacokinetic phase only

  2. Pharmacokinetics of ASP8273 in plasma: tmax [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    tmax: The time of maximum concentration. Pharmacokinetic phase only

  3. Pharmacokinetics of ASP8273 in plasma: tlast [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    tlast: The time of last observed concentration. Pharmacokinetic phase only

  4. Pharmacokinetics of ASP8273 in plasma: CL/F [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    CL/F: Oral clearance. Pharmacokinetic phase only

  5. Pharmacokinetics of ASP8273 in plasma: Vz/F [ Time Frame: Up to Day 5 in each period of Phase 1 (maximum of 10 days) ]
    Vz/F: Apparent volume of distribution. Pharmacokinetic phase only

  6. Safety and tolerability assessed by nature, frequency, and severity of adverse events (AES) [ Time Frame: Up to day 30 ]
    For both pharmacokinetic and postpharmacokinetic phases

  7. Number of participants with vital sign abnormalities and/or adverse events related to treatment [ Time Frame: Up to day 30 ]
    Vital signs include systolic and blood diastolic pressure, temperature and pulse rate. For both pharmacokinetic and postpharmacokinetic phases

  8. Number of participants with laboratory abnormalities and/or adverse events related to treatment [ Time Frame: Up to day 30 ]
    Laboratory values include biochemical, hematological, coagulation and urine analysis. For both pharmacokinetic and postpharmacokinetic phases

  9. Safety assessed by routine 12-lead electrocardiograms (ECG) [ Time Frame: Up to day 30 ]
    Routine 12-lead ECGs will be performed after the subject has been in a supine position for at least 5 minutes. For both pharmacokinetic and postpharmacokinetic phases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has histologically confirmed locally advanced or unresectable Stage IIIB (not amenable to receive curative treatments such as chemo-radiation)/IV or metastatic NSCLC.
  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Subject has an EGFR activating mutation based on local testing.
  • Subject has predicted life expectancy ≥ 12 weeks.
  • Subject must meet all of the following criteria on the laboratory tests. In case of multiple laboratory data within this period, the most recent data should be used.

    • Neutrophil count > 1000/mm^3
    • Platelet count ≥ 7.5 x 10^4/mm^3
    • Hemoglobin > 8.0 g/dL
    • Serum creatinine <2.0 x upper limit of normal (ULN) or estimated glomerular filtration rate of > 50 mL/min as calculated by the Cockcroft Gault Method
    • Total bilirubin < 1.5 × ULN (except for subjects with documented Gilbert's syndrome)
    • AST (Aspartate aminotransferase (GOT) and ALT (Alanine aminotransferase (GPT)) < 3.0 × ULN (upper limit of normal) or ≤ 5 × ULN if subject has documented liver metastases
    • Serum sodium level ≥ 130 mmol/L
  • Subject agrees not to participate in another interventional study while receiving study drug and participating in the present study.
  • 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 (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) 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 blood pregnancy test at the time of screening
    • And if heterosexually active, agrees to consistently use 1 form of highly effective birth control* starting at screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subject must agree not to breastfeed at screening and throughout 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.
  • A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:

    • Agrees to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile as defined below their female partner(s) is utilizing 1 form of highly effective birth control*starting at screening and continue throughout study treatment and for 90 days after the male subject receives their final study drug administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding 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 must be willing to fast for approximately 10 hours predose and 4 hours postdose on day 1 of each period in the pharmacokinetic phase.

    • Highly effective forms of birth control include:

      • Consistent and correct usage of established hormonal contraceptives that inhibit ovulation,
      • Established intrauterine device or intrauterine system.
      • Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used).
      • Male subject is sterile due to a bilateral orchiectomy.

Exclusion Criteria:

  • Subject has an ongoing toxicity ≥ Grade 2 (NCI CTCAE Version 4.03) attributable to prior medication to treat solid tumor (except alopecia) at screening.
  • Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
  • Subject has received treatment with any other agent with antitumor activity including chemotherapy, radiotherapy, or immunotherapy within 14 days as well as EGFR tyrosine kinase inhibitor within 6 days prior to first dose of study drug.
  • Subject has any of the following within 14 days prior to the first dose of study drug:

    • Major surgical procedure (other than study related biopsy), or a major surgical procedure is planned to occur during the planned study duration
    • Blood transfusions or hemopoietic factor therapy
    • Evidence of active infection requiring systemic therapy
  • Subject has symptomatic central nervous system (CNS) metastasis. Subject with previously treated brain or CNS metastases is eligible provided that the subject has recovered from any acute effects of radiotherapy and is not requiring systemic steroids and any whole brain radiation therapy was completed at least 2 weeks prior to study drug administration, or any stereotactic radiosurgery was completed at least 1 week prior to study drug administration.
  • Subject has a known history of a positive test for human immunodeficiency infection.
  • Subject has a known history of a positive test for hepatitis B surface antigen or hepatitis C antibody.
  • Subject has known history of serious hypersensitivity reaction to ASP8273, or any component of the formulation used.
  • Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension 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 III or IV 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 active 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 that makes the subject unsuitable for study participation (e.g., 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 that requires treatment. Prior carcinoma in situ and/or nonmelanoma skin cancer after curative resection are permitted.
  • Subject has received the following within 14 days prior to the first dose of study drug:

    • Strong or moderate CYP3A4 inhibitors or inducers
    • Strong or moderate P-gp inhibitors or inducers

Information from the National Library of Medicine

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): NCT03082300


Locations
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United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
United States, Texas
Renovatio Clinical
The Woodlands, Texas, United States, 77380
United States, Virginia
US Oncology - Virginia Cancer Specialists, P.C. (VCS)
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Senior Medical Astellas Pharma Global Development, Inc.

Additional Information:
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03082300     History of Changes
Other Study ID Numbers: 8273-CL-0112
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
ASP8273
Epidermal growth factor receptor (EGFR) mutations
naquotinib
Non-small cell lung cancer (NSCLC)
Bioequivalence
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Naquotinib
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors