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bosunitib sorbitol

Phase 1

CML | Small molecule | Oncology |Pfizer, Inc.|Last 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

Clinical trial landscape

bosunitib sorbitol · 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

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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

Arm	Type	Description
A- Bosutinib in water	EXPERIMENTAL	200 Mg of bosutinib (50 mg capsule x4) in Water solution
B- bosutinib in sorbitol	EXPERIMENTAL	200 Mg of bosutinib sorbitol base in water solution
C- - bosutinib mannitol	EXPERIMENTAL	200 Mg of bosutinib powder mannitol base in water solution
D - bosutinib in mannitol low sweet	EXPERIMENTAL	200 Mg of bosutinib mannitol low sweet solution
E- - bosutinib in mannitol high sweet	EXPERIMENTAL	200 Mg of bosutinib High % sweet mannitol solution
F- - bosutinib low flavour	EXPERIMENTAL	Taste assessment of 200 Mg of bosutinib low % Flavour
G- bosutinib high flavour	EXPERIMENTAL	Taste assessment of 200 Mg of bosutinib high percentage of flavor in water
H- - bosutinib capsules in low sweet	EXPERIMENTAL	Taste assessment of 200 Mg of bosutinib (50 mg x4 capsules) low % sweet
I - bosutinib capsules high sweet	EXPERIMENTAL	200 Mg of bosutinib (4 X 50 mg capsules)in high % sweetener
J- - bosutinib capsules low flavour	EXPERIMENTAL	Taste assessment of 200 Mg of bosutinib (50 mg X4 capsules) in Low % flavour Water solution
K - bosutinib capsules high flavour	EXPERIMENTAL	Taste assessment of 200 Mg of bosutinib (50 mg X 4 capsules) in high % flavour
L - bosutinib capsules applesauce	EXPERIMENTAL	200 Mg of bosutinib (50 mg x 4 capsules) in applesauce
M - bosutinib capsules full fat yougurt	EXPERIMENTAL	200 Mg of bosutinib (50 mg x 4 capsules) in full fat yogurt
N - bosutinib capsules in water (retest)	EXPERIMENTAL	200 Mg of bosutinib (50 mg x 4 capsules) in Water (retest)

Interventions

Name	Type	Description
200 Mg capsules of bosutinib in Water solution	DRUG	200 mg (4X50) Capsules in water
bosunitib sorbitol	DRUG	200 Mg of bosutinib sorbitol solution
Bosutinib Mannitol	DRUG	Bosutinib mannitol solution
bosutinib in mannitol low sweet	DRUG	bosutinib in mannitol solution low sweet
bosutinib in mannitol high sweet	DRUG	bosutinib in mannitol high sweet
bosutinib taste low flavour	DRUG	bosutinib solution low flavour
bosutinib high flavour	DRUG	bosutinib solution high flavour
bosutinib capsules in applesauce	DRUG	Bosutinib capsules in applesauce
Bosutinib capsules in yogurt	DRUG	bosutinib capsules in yogurt
bosutinib capsules in water	DRUG	sham comparator, bosutinb in water retest
Bosutinib capsules in low sweet	DRUG	bosutinib capsules in low sweet
bosutinib capsules high sweet	DRUG	Bosutinib capsules high sweet
bosutinib capsules low flavour	DRUG	Bosutinib capsules low flavour
bosutinib capsules high flavour	DRUG	bosutinib 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 bosunitib sorbitol

What is bosunitib sorbitol used for?

Bosunitib sorbitol is an investigational small molecule being studied for use in chronic myeloid leukemia (CML). It is currently in Phase 1 clinical development. The drug is being developed by Pfizer, Inc. (NYSE: PFE).

What does bosunitib sorbitol target?

Bosunitib sorbitol is a small molecule being studied for CML. Its specific molecular target has not been disclosed in the available information. The drug is in Phase 1 clinical development by Pfizer, Inc. (NYSE: PFE).

Who makes bosunitib sorbitol?

Bosunitib sorbitol is being developed by Pfizer, Inc. (NYSE: PFE). The drug is an investigational small molecule in Phase 1 clinical development for the treatment of chronic myeloid leukemia (CML).

What phase is bosunitib sorbitol in?

Bosunitib sorbitol is in Phase 1 clinical development. It is an investigational drug being studied for chronic myeloid leukemia (CML) and is not yet approved by regulatory authorities. The developer is Pfizer, Inc. (NYSE: PFE).

What clinical trials is bosunitib sorbitol in?

Bosunitib sorbitol has one completed Phase 1 clinical trial, NCT03747679, titled "Palatability (Taste) of Oral Formulations of Bosutinib." The trial enrolled 8 participants in Belgium and was a controlled, randomized study involving healthy volunteers aged 18 years and older.

Is bosunitib sorbitol the same as bosutinib?

Bosunitib sorbitol appears to be a formulation of bosutinib, as indicated by the clinical trial title referencing oral formulations of bosutinib. The drug is being studied for chronic myeloid leukemia (CML) and is in Phase 1 development by Pfizer, Inc. (NYSE: PFE).