Drug Interaction PotentialPhase 1NCT03291288
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
A Phase 1 study testing Tolbutamide, Midazolam and Pexidartinib in people with Drug Interaction Potential, run by Daiichi Sankyo at 11 sites in 4 countries.
Trial summary
This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents. Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Interaction Potential
- What is being tested?
- Tolbutamide, Midazolam and Pexidartinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 26 Feb 2018to 16 Apr 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is the age of majority in country of residence
- Has a diagnosis of:
- tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations and for whom surgery is not an option (prior pexidartinib is permitted for TGCT patients unless ineffective or not tolerated and there has been a washout period of at least 4 weeks)
- KIT-mutant tumor, including melanoma or gastrointestinal stromal tumor (GIST), for which there is no standard systemic therapy, or
- other solid tumors (all comers) for which there is no standard systemic therapy and there is a rationale for use of pexidartinib at the Investigator's discretion
- If a female of childbearing potential, had a negative serum pregnancy test within 14 days before enrollment, or within 72 hours before enrollment where required
Show all 14Show fewer
- Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:
- intra-uterine device (nonhormonal or hormonal)
- sexual abstinence (only if this is in line with the patient's current lifestyle)
- barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
- Is a surgically sterile male or female, or is postmenopausal for at least 1 year, at least 50 years of age, with a follicle-stimulating hormone level > 40 milli-International units per mL (mIU/mL)
- Has adequate hematologic, hepatic, and renal function as defined by the protocol
- Is able and willing to follow all study procedures
- Has provided a signed informed consent
Who cannot join
- Is pregnant or breastfeeding
- Is unable to swallow oral medication
- Is unable to follow study procedures
- Is taking or has taken any medications or therapies outside of protocol-defined parameters
- Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
- safety and well-being of the participant or offspring
- safety of study staff
- analysis of results
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States8 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mary Crowley Cancer Research
Dallas, Texas, 75230
Karmanos Cancer Center
Detroit, Michigan, 48201
Northwell Health
Lake Success, New York, 10042
Stanford University
Palo Alto, California, 94304
HonorHealth
Scottsdale, Arizona, 85258
University of Arizona
Tucson, Arizona, 85719
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients
This study has two parts.
Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents.
Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types.
In Part 2, the same participants will continue to receive pexidartinib twice daily.
Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.
- Conditions
- Drug Interaction Potential
- Being tested
- Tolbutamide, Midazolam, Pexidartinib
- Keywords
- Tenosynovial Giant Cell Tumors (TGCT), Kit-mutant melanoma, Kit-mutant gastrointestinal stromal tumor (GIST), Cocktail drug-drug interaction (DDI)
- Medical subject headings
- Synovitis, Pigmented Villonodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolbutamideDrug
Also called Orinase
Commercially available tolbutamide
MidazolamDrug
Also called Dormicum, Hypnovel, Versed, Others
Commercially available midazolam
PexidartinibDrug
Also called PLX-3397
Pexidartinib is formulated as opaque, white, 200-mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Pexidartinib | Experimental | Part 1 (Drug-drug Interaction Phase):
On Day 1, all participants will receive a single oral dose each of midazolam (2 mg) and tolbutamide (500 mg). On Day 3, pexidartinib (800 mg/d) in twice daily (400 mg BID) dosing will be initiated and continue throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) will be co-administered with the morning pexidartinib dose (400 mg). On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) will be co-administered with the morning dose of pexidartinib (400 mg).
Part 2 (Efficacy and Safety Phase):
All participants will continue to receive pexidartinib 400 mg BID. Receives: Drug: Tolbutamide; Drug: Midazolam; Drug: Pexidartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Measured: Baseline to 15 days post treatment
Overall Summary of Treatment-emergent Adverse Events
Adverse events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.
Measured: Baseline to 1 year post treatment
Secondary outcomes (7)
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Pexidartinib and ZAAD-1006a Metabolite
Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Pexidartinib and ZAAD-1006a Metabolite
Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Pexidartinib and ZAAD-1006a Metabolite
Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam Metabolite, 1-Hydroxy Midazolam
Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam Metabolite, 1-Hydroxy Midazolam
Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam Metabolite, 1-Hydroxy Midazolam
Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.
Measured: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Metabolite to Parent Ratio (MPR) for Midazolam
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Plasma pharmacokinetic parameters calculated for Midazolam metabolite. 1-hydroxy midazolam and midazolam for the MPR value.
Measured: Baseline to 13 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start26 Feb 2018
- Primary completion26 Sep 2018
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Interaction PotentialStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Sequential
- Model description
- Open-label, single sequence study with 2 parts
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study chair, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291288
- Sponsor's protocol ID
- PL3397-A-U126
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2017
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.
PubMed 33289960
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients
- ClinicalTrials.gov ID
- NCT03291288
- Acronym / sponsor ID
- PL3397-A-U126
- Conditions
- Drug Interaction Potential
- Keywords
- Tenosynovial Giant Cell Tumors (TGCT), Kit-mutant melanoma, Kit-mutant gastrointestinal stromal tumor (GIST), Cocktail drug-drug interaction (DDI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two parts.
Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents.
Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types.
In Part 2, the same participants will continue to receive pexidartinib twice daily.
Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single sequence study with 2 parts
| Arm | Type | Receives |
|---|---|---|
| Pexidartinib | Experimental | Drug: Tolbutamide, Drug: Midazolam, Drug: PexidartinibPart 1 (Drug-drug Interaction Phase): On Day 1, all participants will receive a single oral dose each of midazolam (2 mg) and tolbutamide (500 mg). On Day 3, pexidartinib (800 mg/d) in twice daily (400 mg BID) dosing will be initiated and continue throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) will be co-administered with the morning pexidartinib dose (400 mg). On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) will be co-administered with the morning dose of pexidartinib (400 mg). Part 2 (Efficacy and Safety Phase): All participants will continue to receive pexidartinib 400 mg BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is the age of majority in country of residence
- Has a diagnosis of:
- If a female of childbearing potential, had a negative serum pregnancy test within 14 days before enrollment, or within 72 hours before enrollment where required
- Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:
- Is a surgically sterile male or female, or is postmenopausal for at least 1 year, at least 50 years of age, with a follicle-stimulating hormone level > 40 milli-International units per mL (mIU/mL)
Key exclusion criteria (8 listed)
- Is pregnant or breastfeeding
- Is unable to swallow oral medication
- Is unable to follow study procedures
- Is taking or has taken any medications or therapies outside of protocol-defined parameters
- Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
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 |
|---|---|---|
| TolbutamideAlso: OrinaseCommercially available tolbutamide | Drug | Pexidartinib |
| MidazolamAlso: Dormicum, Hypnovel, Versed, OthersCommercially available midazolam | Drug | Pexidartinib |
| PexidartinibAlso: PLX-3397Pexidartinib is formulated as opaque, white, 200-mg capsules | Drug | Pexidartinib |
Primary outcome
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam
Time frame: Baseline to 15 days post treatment
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide
Time frame: Baseline to 15 days post treatment
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam
Time frame: Baseline to 15 days post treatment
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide
Time frame: Baseline to 15 days post treatment
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam
Time frame: Baseline to 15 days post treatment
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide
Time frame: Baseline to 15 days post treatment
Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Overall Summary of Treatment-emergent Adverse Events
Time frame: Baseline to 1 year post treatment
Adverse events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.
7 secondary outcomes
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Pexidartinib and ZAAD-1006a Metabolite
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Pexidartinib and ZAAD-1006a Metabolite
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Pexidartinib and ZAAD-1006a Metabolite
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam Metabolite, 1-Hydroxy Midazolam
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam Metabolite, 1-Hydroxy Midazolam
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam Metabolite, 1-Hydroxy Midazolam
Time frame: Baseline to 13 days post treatment
Pharmacokinetic Analysis: Metabolite to Parent Ratio (MPR) for Midazolam
Time frame: Baseline to 13 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33289960Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
Global Clinical Leader study chair
Daiichi Sankyo
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolbutamide, Midazolam and Pexidartinib in people with Drug Interaction Potential, run by Daiichi Sankyo at 11 sites in 4 countries.
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 14 inclusion and 8 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, New Zealand, Taiwan. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam (time frame: Baseline to 15 days post treatment). The study lists 7 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 NCT03291288, 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 14 May 2021.