caffeine - Advanced Solid Tumors, Excluding Breast Cancer | Phase 1 | Novartis AG | BiopharmaWatch

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caffeine

Phase 1

Advanced Solid Tumors, Excluding Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 21, 2020

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

UNCONTROLLEDBiomarker

Total Trials1

Total Enrollment39

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT01596647	Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors	PHASE1	COMPLETED	39	—	—	May 1, 2012	Jul 1, 2014	Dec 21, 2020	5	United States

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Study Endpoints

Primary Endpoints

Probe substrate pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters: AUCtlast (Area Under the Curve)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters: AUCinf

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters:Tmax (Time to maximum concentration)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters: HL (Half-life time)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters:CL/F (Apparent Oral Clearance)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Probe substrate PK parameters:Vz/F (apparent volume of distribution)

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Secondary Endpoints

Frequency and severity of AEs (Adverse Events)

up to at least 30 days after the last dose of dovitinib (TKI258)

Preliminary evidence of antitumor activity of dovitinib (TKI258)

every 8 weeks until progression of disease

Frequency and severity of SAEs (Serious Adverse Events)

up to at least 30 days after the last dose of dovitinib (TKI258)

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
TKI258 (dovitinib)	EXPERIMENTAL	dovitinib, 5 days on / 2 days off dose schedule

Interventions

Name	Type	Description
caffeine	DRUG	single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
diclofenac	DRUG	single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
omeprazole	DRUG	single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
midazolam	DRUG	single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
TKI258	DRUG	dovitinib, 5 days on / 2 days off dose schedule

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Eligibility Criteria

Age Range18 Years — N/A

SexALL

Healthy VolunteersNo

Study Sites5

Inclusion Criteria: * Patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists * ECOG performance status 0 or 1 and anticipated life expecta...

Countries:United States

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