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of bosutinib in Water

Phase 1

CML | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Jul 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

of bosutinib in Water clinical trials

of bosutinib in Water · 1 trial · 1 indication

Phase 1 1
NCT03747679Palatability (Taste) of Oral Formulations of BosutinibCML
COMPLETED8 Analytics
PHASE1COMPLETED
Palatability (Taste) of Oral Formulations of Bosutinib
CML
NCT037476798
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Study Endpoints

Primary Endpoints

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib in Water)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib sorbitol)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol low sweet)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use(Bosutinib mannitol high sweet)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol in low flavour strawberry)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol high flavour strawberry)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low sweet
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high sweet
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low flavour
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high flavour
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) applesauce
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (bosutinib 4 capsules 50 mg bosutinib in yogurt
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4 in water retest)
baseline to one month

This study will enable the selection of the commercial formulation for pediatric use of bosutinib

Secondary Endpoints

Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution bosutinib 200 mg sorbitol
Baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of 200 mg bosutinib powder mannitol solution
baseline to one month
Number of patients with treatment emergent treatment related adverse events bosutinib 50 mg x4 capsules in water
baseline to one month
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
A- Bosutinib in waterEXPERIMENTAL200 Mg of bosutinib (50 mg capsule x4) in Water solution
B- bosutinib in sorbitolEXPERIMENTAL200 Mg of bosutinib sorbitol base in water solution
C- - bosutinib mannitolEXPERIMENTAL200 Mg of bosutinib powder mannitol base in water solution
D - bosutinib in mannitol low sweetEXPERIMENTAL200 Mg of bosutinib mannitol low sweet solution
E- - bosutinib in mannitol high sweetEXPERIMENTAL200 Mg of bosutinib High % sweet mannitol solution
F- - bosutinib low flavourEXPERIMENTALTaste assessment of 200 Mg of bosutinib low % Flavour
G- bosutinib high flavourEXPERIMENTALTaste assessment of 200 Mg of bosutinib high percentage of flavor in water
H- - bosutinib capsules in low sweetEXPERIMENTALTaste assessment of 200 Mg of bosutinib (50 mg x4 capsules) low % sweet
I - bosutinib capsules high sweetEXPERIMENTAL200 Mg of bosutinib (4 X 50 mg capsules)in high % sweetener
J- - bosutinib capsules low flavourEXPERIMENTALTaste assessment of 200 Mg of bosutinib (50 mg X4 capsules) in Low % flavour Water solution
K - bosutinib capsules high flavourEXPERIMENTALTaste assessment of 200 Mg of bosutinib (50 mg X 4 capsules) in high % flavour
L - bosutinib capsules applesauceEXPERIMENTAL200 Mg of bosutinib (50 mg x 4 capsules) in applesauce
M - bosutinib capsules full fat yougurtEXPERIMENTAL200 Mg of bosutinib (50 mg x 4 capsules) in full fat yogurt
N - bosutinib capsules in water (retest)EXPERIMENTAL200 Mg of bosutinib (50 mg x 4 capsules) in Water (retest)

Interventions

NameTypeDescription
200 Mg capsules of bosutinib in Water solutionDRUG200 mg (4X50) Capsules in water
bosunitib sorbitolDRUG200 Mg of bosutinib sorbitol solution
Bosutinib MannitolDRUGBosutinib mannitol solution
bosutinib in mannitol low sweetDRUGbosutinib in mannitol solution low sweet
bosutinib in mannitol high sweetDRUGbosutinib in mannitol high sweet
bosutinib taste low flavourDRUGbosutinib solution low flavour
bosutinib high flavourDRUGbosutinib solution high flavour
bosutinib capsules in applesauceDRUGBosutinib capsules in applesauce
Bosutinib capsules in yogurtDRUGbosutinib capsules in yogurt
bosutinib capsules in waterDRUGsham comparator, bosutinb in water retest
Bosutinib capsules in low sweetDRUGbosutinib capsules in low sweet
bosutinib capsules high sweetDRUGBosutinib capsules high sweet
bosutinib capsules low flavourDRUGBosutinib capsules low flavour
bosutinib capsules high flavourDRUGbosutinib capsules in high flavour
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Age and Sex: 1. Female participants of non-childbearing potential and/or male participants able to father children must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD). -Refer to Appendix 4 for reproductive criteria for male (...

Countries:Belgium
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Frequently asked questions about of bosutinib in Water

What is bosutinib in Water?

Bosutinib in Water refers to a liquid oral preparation made by mixing 200 mg bosutinib capsules with water. It was studied in a Phase 1 palatability trial evaluating the taste of oral bosutinib formulations. Bosutinib is a small molecule developed by Pfizer, Inc. (ticker: PFE) for chronic myeloid leukemia (CML).

What is bosutinib in Water used for in CML?

Bosutinib in Water is an oral liquid formulation of bosutinib being studied for chronic myeloid leukemia (CML). The only clinical trial of this specific water-based preparation was a Phase 1 palatability study in healthy adult volunteers, not a treatment efficacy trial. It is not an approved formulation for CML.

Who makes bosutinib in Water?

Pfizer, Inc. (ticker: PFE) is the developer of bosutinib in Water. Pfizer is the company behind the bosutinib capsule formulation that was mixed with water for the palatability study.

What phase is bosutinib in Water in?

Bosutinib in Water is in Phase 1 development. The single clinical trial of this water-based oral formulation was a completed Phase 1 palatability study. It is an investigational preparation and is not an FDA-approved formulation.

What clinical trials is bosutinib in Water in?

Bosutinib in Water has been studied in one clinical trial: NCT03747679, titled "Palatability (Taste) of Oral Formulations of Bosutinib." This completed Phase 1 trial enrolled 8 healthy adult volunteers in Belgium and evaluated the taste of oral bosutinib formulations.

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