bosunitib sorbitol - CML | Phase 1 | Pfizer, Inc. | BiopharmaWatch

Recently added Catalysts

bosunitib sorbitol

Phase 1

CML | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 10, 2020

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

Premium

Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

Premium

Trial Design

RandomizedCONTROLLEDBiomarker

Total Trials1

Total Enrollment8

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03747679	Palatability (Taste) of Oral Formulations of Bosutinib	PHASE1	COMPLETED	8	—	—	Nov 22, 2018	Jan 14, 2019	Jul 10, 2020	1	Belgium

Unlock Drug Trial Details

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

Unlock Study Endpoints

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

Unlock Study Design Details

Eligibility Criteria

Age Range18 Years — 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

Unlock Eligibility Criteria