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Epidermal Growth Factor Receptor (EGFR) MutationsPhase 1NCT02674555

A Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors

A Phase 1 study testing radio-labeled naquotinib and naquotinib in people with Epidermal Growth Factor Receptor (EGFR) Mutations and Solid Tumors, run by Astellas Pharma Global Development, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a study to investigate the absorption, metabolism and excretion of [14C] labeled ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This study consists of two parts (A and B). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
radio-labeled naquotinib and naquotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Nov 2016to 15 Nov 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has histologically or cytologically confirmed metastatic or locally advanced, unresectable solid tumors harboring EGFR mutations.
  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Subject must meet all of the following criteria on the laboratory tests that will be performed within 7 days prior to enrollment. 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 × 104/mm3
  • Hemoglobin ≥ 9.0 g/dL
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  • Lymphocyte count ≥ 500/mm3
  • Estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Cockcroft-Gault Method
  • Total bilirubin (TBL) < 1.5 × upper limit of normal (ULN; except for subjects with documented Gilbert's syndrome)
  • Aspartate aminotransferase (AST) and ALT < 3.0 × ULN
  • Serum sodium level is ≥ 130 mmol/L
  • Female subject must either be:
  • Of nonchild bearing potential:
  • Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
  • Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening).
  • 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,
  • Must have a negative serum pregnancy test at screening and day -1, and
  • If heterosexually active must use two forms of birth control* (at least one 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 his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one 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.
  • Acceptable forms of birth control include:
  • Established use of oral, injected or implanted hormonal methods of contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Who cannot join

  • Subject has an ongoing toxicity ≥ Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
  • Subject has known history of serious hypersensitivity reaction to ASP8273, or any component of the formulation used.
  • Subject has received investigational therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug.
  • Subject has received a prior EGFR inhibitor within 6 days prior to the first dose of study drug.
  • Subject has had any of the following within 14 days prior to the first dose of study drug:
  • A treatment with any other agent with antitumor activity including chemotherapy, radiotherapy, or immunotherapy
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  • A major surgical procedure (other than study related biopsy), or a major surgical is planned to occur during the study
  • 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 are eligible provided that the subject has recovered from any acute effects of radiotherapy and is not requiring 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 the first dose of study drug.
  • Subject has ≥ CTCAE v4.03 Grade 2 neuropathy.
  • Subject has a known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV).
  • Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.
  • Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
  • Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure > 150/100 mmHg) or active bleeding diatheses.
  • 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 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 (e.g., advanced cataracts, glaucoma, or subject is unable to undergo a comprehensive ophthalmologic exam).
  • Subject has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the first dose of study drug.
  • 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 who has received strong/moderate inhibitors or inducers of CYP3A4 within 14 days prior to the first dose of study drug.

About this study

Official title: A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

This is a study to investigate the absorption, metabolism and excretion of [14C] labeled ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This study consists of two parts (A and B).

Read the detailed description

This study consists of two parts (A and B).

In Part A, eligible subjects will be admitted to the site on day -1 and remain confined at the site until postdosing discharge criteria are met. Subjects will receive a single dose of [14C] ASP8273 solution on study day 1.

Once Part A has been completed, subjects may elect to continue participation in Part B. Subjects will receive oral administration of ASP8273 (nonradiolabeled) once daily in 28-day cycles.

Being tested
radio-labeled naquotinib, naquotinib
Keywords
Phase 1, Metabolism, Excretion, Absorption, [14C]-radioactivity, Pharmacokinetics, naquotinib, Oncology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radio-labeled naquotinibDrug

    Also called ASP8273

    Oral administration

  • naquotinibDrug

    Also called ASP8273

    Oral administration

Study groups in NCT02674555
Study groupRoleWhat they receive
ASP8273ExperimentalTwo Parts - Part A: 14C-radio labeled; Part B: non radio labeled (optional)
Receives: Drug: radio-labeled naquotinib; Drug: naquotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Radioactivity in whole blood: AUCinf

    AUCinf: area under the concentration-time curve from the time of dosing extrapolated to time infinity

    Measured: Up to 14 days

  2. Part A: Radioactivity in whole blood: AUClast

    AUClast: area under the concentration-time curve from the time of dosing to the last measurable concentration

    Measured: Up to 14 days

  3. Part A: Radioactivity in whole blood: Cmax

    Cmax: maximum concentration

    Measured: Up to 14 days

  4. Part A: Radioactivity in whole blood: tmax

    tmax: time to maximum concentration

    Measured: Up to 14 days

  5. Part A: Radioactivity in whole blood: t1/2

    t1/2: apparent terminal elimination half-life

    Measured: Up to 14 days

  6. Part A: Radioactivity in plasma: AUCinf

    Measured: Up to 14 days

  7. Part A: Radioactivity in plasma: AUClast

    Measured: Up to 14 days

  8. Part A: Radioactivity in plasma: Cmax

    Measured: Up to 14 days

  9. Part A: Radioactivity in plasma: tmax

    Measured: Up to 14 days

  10. Part A: Radioactivity in plasma: t1/2

    Measured: Up to 14 days

  11. Part A: Radioactivity ratio for whole blood/plasma concentration (per time point.)

    Measured: Up to 14 days

  12. Part A: Radioactivity ratio for whole blood/plasma AUCinf

    Measured: Up to 14 days

  13. Part A: Radioactivity ratio for whole blood/plasma AUClast

    Measured: Up to 14 days

  14. Part A: Excretion ratio of radioactivity in urine

    Measured: Up to 14 days

  15. Part A: Cumulative excretion of radioactivity in urine

    Measured: Up to 14 days

  16. Part A: Excretion ratio of radioactivity in feces

    Measured: Up to 14 days

  17. Part A: Cumulative excretion of radioactivity in feces

    Measured: Up to 14 days

  18. Part A: Total excretion ratio of radioactivity in urine and feces

    Measured: Up to 14 days

  19. Part A: Total cumulative excretion of radioactivity in urine and feces

    Measured: Up to 14 days

  20. Part A: Radioactivity in emesis (if applicable)

    Measured: Up to 14 days

  21. Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: AUCinf

    Measured: Up to 14 days

  22. Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: AUClast

    Measured: Up to 14 days

  23. Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: Cmax

    Measured: Up to 14 days

  24. Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: tmax

    Measured: Up to 14 days

  25. Part A: Pharmacokinetics of ASP8273 and possible metabolites in plasma: t1/2

    Measured: Up to 14 days

  26. Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine: (Aelast)

    Aelast: cumulative amount of drug excreted from time of dosing up to the collection time of the last measurable concentration

    Measured: Up to 14 days

  27. Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine CLr

    CLr: renal clearance

    Measured: Up to 14 days

  28. Part A: Pharmacokinetics of ASP8273 and possible metabolites in urine: % of dose excreted (Aelast%)

    Measured: Up to 14 days

Secondary outcomes (4)

  1. Part A: Profiling of possible metabolites of ASP8273 in plasma

    Identification and possible quantification of metabolites in plasma

    Measured: Up to 14 days

  2. Part A: Profiling of possible metabolites of ASP8273 in urine

    Identification and possible quantification of metabolites in urine

    Measured: Up to 14 days

  3. Part A: Profiling of possible metabolites of ASP8273 in feces

    Identification and possible quantification of metabolites in feces

    Measured: Up to 14 days

  4. Part A and Part B: Safety profile assessed by adverse event reporting, vital signs, electrocardiograms (ECG), clinical laboratory tests, and physical examinations

    Vital signs include oral temperature, pulse, and blood pressure. Clinical laboratory evaluations include hematology, chemistry and urinalysis.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion15 Nov 2016
  4. Study completion15 Nov 2016

Why it stopped: Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674555
Sponsor's protocol ID
8273-CL-0104
Status last verified
Jul 2017
First submitted
21 Jan 2016
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing radio-labeled naquotinib and naquotinib in people with Epidermal Growth Factor Receptor (EGFR) Mutations and Solid Tumors, run by Astellas Pharma Global Development, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Radioactivity in whole blood: AUCinf (time frame: Up to 14 days). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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