A Phase 1 interventional study of Tolbutamide and Midazolam in Drug Interaction Potential, sponsored by Daiichi Sankyo. Completed at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment
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.
20 studies on the registry are indexed under Synovitis, Pigmented Villonodular; 2 are open to participants now.
This study's enrollment of 32 is below the median of 36 across 17 interventional studies indexed under Synovitis, Pigmented Villonodular.
Browse Synovitis, Pigmented Villonodular studies →Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has a diagnosis of:
Is a non-sterile male or female willing to use of one of the protocol-defined highly effective methods:
Exclusion Criteria:
Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tolbutamide · Drug: Midazolam · Drug: Pexidartinib
Commercially available tolbutamide
Also known as: Orinase
Commercially available midazolam
Also known as: Dormicum, Hypnovel, Versed, Others
Pexidartinib is formulated as opaque, white, 200-mg capsules
Also known as: PLX-3397
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline to 1 year post treatment
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Baseline to 13 days post treatment
A total of 32 participants who met all inclusion and no exclusion criteria were enrolled in the study; 2 participants did not receive pexidartinib treatment.
| Milestone | Part 1: Drug-drug Interaction Phase | Part 2: Pexidartinib Only |
|---|---|---|
| Started | 32 | 0 |
| Completed | 26 | 0 |
| Not completed | 6 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Disease progression | 1 | 0 |
| Withdrew: Other | 3 | 0 |
| Milestone | Part 1: Drug-drug Interaction Phase | Part 2: Pexidartinib Only |
|---|---|---|
| Started | 0 | 26 |
| Completed | 0 | 24 |
| Not completed | 0 | 2 |
| Withdrew: Ongoing | 0 | 2 |
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).
| ng/mL | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam | 13.6 ± 6.8 | 12.0 ± 4.9 | 9.7 ± 4.1 |
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).
| ng/mL | Part 1: Tolbutamide Only | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide | 44400 ± 13100 | 46700 ± 16300 | 44400 ± 12200 |
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).
| hours | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam | 0.525 (0.333 to 1.37) | 0.5 (0.417 to 1.42) | 0.5 (0.333 to 0.917) |
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).
| hours | Part 1: Tolbutamide Only | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide | 2.90 (1 to 8.2) | 2.94 (1.52 to 8.08) | 3.17 (2.45 to 6.02) |
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).
| ng*hour/mL | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam | 43.7 ± 34.1 | 31.6 ± 19.6 | 18.5 ± 8.2 |
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).
| ng*hour/mL | Part 1: Tolbutamide Only | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide | 500000 ± 196000 | 585000 ± 234000 | 700000 ± 207000 |
Adverse events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.
| Participants | Part 1: Drug-drug Interaction Phase | Part 2: Pexidartinib Only |
|---|---|---|
| TEAEs | 24 | 23 |
| Pexidartinib-related TEAEs | 16 | 20 |
| Treatment-emergent serious adverse events (SAEs) | 5 | 5 |
| Pexidartinib-related SAEs | 1 | 1 |
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.
| ng/mL | Part 1: Pexidartinib (Cycle 1, Day 1) | Part 1: Pexidartinib (Cycle 1, Day 11) |
|---|---|---|
| Pexidartinib | 3140 ± 1250 | 8320 ± 2530 |
| ZAAD-1006a | 3330 ± 1520 | 13500 ± 5980 |
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.
| hours | Part 1: Pexidartinib (Cycle 1, Day 1) | Part 1: Pexidartinib (Cycle 1, Day 11) |
|---|---|---|
| Pexidartinib | 2.03 (1.08 to 7.83) | 1.93 (0.92 to 8.03) |
| ZAAD-1006a | 6.04 (2.37 to 9.07) | 2.53 (0 to 8.25) |
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.
| ng*hour/mL | Part 1: Pexidartinib (Cycle 1, Day 1) | Part 1: Pexidartinib (Cycle 1, Day 11) |
|---|---|---|
| Pexidartinib | 14400 ± 5870 | 53200 ± 17800 |
| ZAAD-1006a | 18300 ± 7240 | 102000 ± 44100 |
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.
| ng/mL | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam Metabolite, 1-Hydroxy Midazolam | 49.7 ± 17.9 | 52.1 ± 17.4 | 55.7 ± 17.4 |
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.
| hours | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam Metabolite, 1-Hydroxy Midazolam | 1.0 (0.333 to 1.45) | 0.933 (0.417 to 1.37) | 0.833 (0.383 to 1.55) |
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.
| ng*hour/mL | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam Metabolite, 1-Hydroxy Midazolam | 200 ± 93 | 206 ± 95.5 | 212 ± 99.6 |
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.
| Ratio | Part 1: Midazolam Only | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) |
|---|---|---|---|
| Pharmacokinetic Analysis: Metabolite to Parent Ratio (MPR) for Midazolam | 587 ± 359 | 750 ± 391 | 1220 ± 657 |
Collected over Adverse events were collected after first dose up to 28 days after the last dose of study drug, up to 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Drug-drug Interaction Phase | 1/30 (3.3%) | 5/30 (16.7%) | 24/30 (80%) |
| Part 2: Pexidartinib Only | 0/25 (0%) | 5/25 (20%) | 23/25 (92%) |
| Event | Part 1: Drug-drug Interaction Phase | Part 2: Pexidartinib Only |
|---|---|---|
| Pericardial effusionCardiac disorders | 0/30 | 1/25 |
| Cardiac tamponadeCardiac disorders | 0/30 | 1/25 |
| OesophagitisGastrointestinal disorders | 0/30 | 1/25 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/30 | 1/25 |
| CholestasisHepatobiliary disorders | 0/30 | 1/25 |
| PneumoniaImmune system disorders | 0/30 | 1/25 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/30 | 1/25 |
| Chest wall haematomaMusculoskeletal and connective tissue disorders | 0/30 | 1/25 |
| Malignant pleural effusionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 1/25 |
| Malignant bowel obstructionGastrointestinal disorders | 1/30 | 0/25 |
| Event | Part 1: Drug-drug Interaction Phase | Part 2: Pexidartinib Only |
|---|---|---|
| Hair colour changesSkin and subcutaneous tissue disorders | 0/30 | 10/25 |
| FatigueGeneral disorders | 4/30 | 7/25 |
| White blood cell count decreasedInvestigations | 1/30 | 6/25 |
| AnemiaBlood and lymphatic system disorders | 5/30 | 4/25 |
| Aspartate aminotransferase increasedInvestigations | 5/30 | 1/25 |
| VomitingGastrointestinal disorders | 2/30 | 4/25 |
| Neutrophil count decreasedInvestigations | 0/30 | 4/25 |
| HypophosphataemiaMetabolism and nutrition disorders | 1/30 | 4/25 |
| Decreased appetiteMetabolism and nutrition disorders | 2/30 | 4/25 |
| DiarrheaGastrointestinal disorders | 4/30 | 0/25 |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 19 |
| >=65 years | 9 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 50.8 ± 19.3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 15 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
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Studies of the drug tested here: Pexidartinib
Synovitis, Pigmented Villonodular →