Advanced Solid TumorsPhase 1NCT02456883
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
A Phase 1 study testing gilteritinib and 14C-labeled gilteritinib in people with Advanced Solid Tumors and Pharmacokinetics of 14C-labeled Gilteritinib, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib
- What is being tested?
- gilteritinib and 14C-labeled gilteritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2016to 19 Jun 2017
- 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 had histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or nonmeasurable disease) for which no standard therapy is available.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Subject must have a life expectancy > 12 weeks.
- Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ≤ Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia.
- Subject has adequate bone marrow, renal and hepatic function at baseline, as demonstrated by the following:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
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- Platelet count ≥ 100,000 cells/mm3
- Hemoglobin (Hb) ≥ 9 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 60 mL/min if the serum creatinine is > 1.5 x ULN
- Total bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (or < 5 x ULN in subjects with liver metastases or hepatocellular carcinoma).
- 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 60 days after the final study drug administration and have a negative serum or urine pregnancy test at screening, and if heterosexually active, agree to consistently use 2 forms of birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and for 60 days after final study drug administration.
- Female subject must not be breastfeeding at screening or during the study period, and for 60 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period and for 60 days after final study drug administration.
- Male subject and a female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 120 days after the final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after final study drug administration.
- Subject must be willing to comply with all procedures and assessments.
Who cannot join
- Subject has received more than 5 prior cytotoxic agent-containing regimens.
- Subject has symptomatic central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination. Subject with prior brain metastases must:
- have stable neurologic status post administration of local therapy (surgery or radiation) for a minimum of 2 weeks following completion of the definitive therapy.
- be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs).
- Subject has had major surgery within 4 weeks prior to the first study dose.
- Subject has had chemotherapy within 4 weeks prior to the first study dose.
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- Subject has had radiation therapy within 4 weeks prior to the first study dose.
- Subject with known hepatitis B surface antigen (HBsAg) positive status; or known or suspected active hepatitis C infection; or known human immunodeficiency virus (HIV) positive.
- Subject with malabsorption syndrome or disease or condition significantly affecting gastrointestinal function.
- Subject with significant or uncontrolled cardiac, renal, hepatic or other systemic disorders; or significant psychological conditions at baseline that in the investigator's opinion, makes the subject unsuitable for study participation.
- Subject with electrocardiogram (ECG) abnormalities on a 12-lead ECG performed within 14 days before start of the study drug that are considered by the Investigator to be clinically significant.
- Subject who has received strong or moderate inhibitors (e.g., ketoconazole or fluconazole) or inducers (e.g., rifampin or phenytoin) of cytochrome P450 (CYP)3A4 or of P-glycoprotein (P-gp), or substrates of multidrug and toxin extrusion (MATE)1 with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject within 2 weeks prior to start of study treatment and while on study.
- Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor, with the exception of drugs that are considered absolutely essential for the care of the subject.
- Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to the initiation of screening.
- Subject has a known history of serious hypersensitivity to ASP2215, or any component of the formulation used.
- Subject who 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 had any of the following within 14 days prior to the first dose of study drug:
- blood transfusion or hemopoietic factor therapy
- evidence of active infection requiring systemic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib.
This study will also evaluate the safety of repeated oral administration of gilteritinib in subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.
Read the detailed description
Participants will be admitted for evaluation to the clinical research unit on day 14 for potentially up to 14 days (day 29). At approximately days 36 and 45 participants will return to the clinic (for 3 days) for additional sample collection.
- Being tested
- gilteritinib, 14C-labeled gilteritinib
- Keywords
- ASP2215, 14C-labeled gilteritinib, Advanced Solid Tumors, Pharmacokinetics, gilteritinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gilteritinibDrug
Also called ASP2215
oral
14C-labeled gilteritinibDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| gilteritinib and 14C-labeled gilteritinib | Experimental | Gilteritinib will be taken once daily on study days 1 through 14 and days 16 through 47. On day 15, each participant will be given a single dose of 14C-labeled gilteritinib. Receives: Drug: gilteritinib; Drug: 14C-labeled gilteritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): AUCtau
Area under the concentration curve over the dosing interval (AUCtau)
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): Cmax
Maximum concentration (Cmax)
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): tmax
Time of maximum concentration (tmax)
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): t1/2
Terminal elimination half-life (t1/2)
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): CL/F
Apparent body clearance after extravascular dosing (CL/F)
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): AUCtau
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): Cmax
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): tmax
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): t1/2
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): CL/F
Measured: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity ratio of whole blood/plasma concentrations): AUC
Area under the concentration (AUC)
Measured: Days 15 - 46
Excretion rate of 14C-labeled gilteritinib (radioactivity in urine)
Percent of dose excreted in urine
Measured: Days 15 - 46
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in urine)
Cumulative total of radioactivity excreted in urine
Measured: Days 15 - 46
Excretion rate of 14C-labeled gilteritinib (radioactivity in feces)
Percent of dose excreted in feces
Measured: Days 15 - 46
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in feces)
Cumulative total of radioactivity excreted in feces
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): AUCtau
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): Cmax
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): tmax
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): CL/F
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): Aetau
Cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): CLR
Renal clearance (CLR)
Measured: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): AETAU%
Percentage of study drug dose excreted into urine over the time interval between consecutive dosing (AETAU%)
Measured: Days 15 - 46
Secondary outcomes (1)
Metabolite identification of gilteritinib in plasma, urine and feces
Measured: Days 15 - 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start4 Mar 2016
- Primary completion20 May 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456883
- Sponsor's protocol ID
- 2215-CL-0105
- Status last verified
- Oct 2024
- First submitted
- 27 May 2015
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
- Expanded access
- Available
Publications
James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.
PubMed 32304015
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02456883
- Acronym / sponsor ID
- 2215-CL-0105
- Keywords
- ASP2215, 14C-labeled gilteritinib, Advanced Solid Tumors, Pharmacokinetics, gilteritinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib.
This study will also evaluate the safety of repeated oral administration of gilteritinib in subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.
Detailed description
Participants will be admitted for evaluation to the clinical research unit on day 14 for potentially up to 14 days (day 29). At approximately days 36 and 45 participants will return to the clinic (for 3 days) for additional sample collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gilteritinib and 14C-labeled gilteritinib | Experimental | Drug: gilteritinib, Drug: 14C-labeled gilteritinibGilteritinib will be taken once daily on study days 1 through 14 and days 16 through 47. On day 15, each participant will be given a single dose of 14C-labeled gilteritinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject had histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or nonmeasurable disease) for which no standard therapy is available.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Subject must have a life expectancy > 12 weeks.
- Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ≤ Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia.
- Subject has adequate bone marrow, renal and hepatic function at baseline, as demonstrated by the following:
Key exclusion criteria (19 listed)
- Subject has received more than 5 prior cytotoxic agent-containing regimens.
- Subject has symptomatic central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination. Subject with prior brain metastases must:
- Subject has had major surgery within 4 weeks prior to the first study dose.
- Subject has had chemotherapy within 4 weeks prior to the first study dose.
- Subject has had radiation therapy within 4 weeks prior to the first study dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gilteritinibAlso: ASP2215oral | Drug | gilteritinib and 14C-labeled gilteritinib |
| 14C-labeled gilteritiniboral | Drug | gilteritinib and 14C-labeled gilteritinib |
Primary outcome
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): AUCtau
Time frame: Days 15 - 46
Area under the concentration curve over the dosing interval (AUCtau)
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): Cmax
Time frame: Days 15 - 46
Maximum concentration (Cmax)
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): tmax
Time frame: Days 15 - 46
Time of maximum concentration (tmax)
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): t1/2
Time frame: Days 15 - 46
Terminal elimination half-life (t1/2)
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): CL/F
Time frame: Days 15 - 46
Apparent body clearance after extravascular dosing (CL/F)
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): AUCtau
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): Cmax
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): tmax
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): t1/2
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): CL/F
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity ratio of whole blood/plasma concentrations): AUC
Time frame: Days 15 - 46
Area under the concentration (AUC)
Excretion rate of 14C-labeled gilteritinib (radioactivity in urine)
Time frame: Days 15 - 46
Percent of dose excreted in urine
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in urine)
Time frame: Days 15 - 46
Cumulative total of radioactivity excreted in urine
Excretion rate of 14C-labeled gilteritinib (radioactivity in feces)
Time frame: Days 15 - 46
Percent of dose excreted in feces
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in feces)
Time frame: Days 15 - 46
Cumulative total of radioactivity excreted in feces
Pharmacokinetics of gilteritinib (in plasma): AUCtau
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): Cmax
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): tmax
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): CL/F
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): Aetau
Time frame: Days 15 - 46
Cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)
Pharmacokinetics of gilteritinib (in urine): CLR
Time frame: Days 15 - 46
Renal clearance (CLR)
Pharmacokinetics of gilteritinib (in urine): AETAU%
Time frame: Days 15 - 46
Percentage of study drug dose excreted into urine over the time interval between consecutive dosing (AETAU%)
1 secondary outcome
Metabolite identification of gilteritinib in plasma, urine and feces
Time frame: Days 15 - 46
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 32304015James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gilteritinib and 14C-labeled gilteritinib in people with Advanced Solid Tumors and Pharmacokinetics of 14C-labeled Gilteritinib, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 19 inclusion and 19 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): AUCtau (time frame: Days 15 - 46). The study lists 22 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 NCT02456883, which also lists 1 linked publication.
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 5 Nov 2024.