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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

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

caffeine · 1 trial · 1 indication

Phase 1 1
NCT01596647Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid TumorsAdvanced Solid Tumors, Excluding Breast Cancer
COMPLETED39 Analytics
PHASE1COMPLETED
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors
Advanced Solid Tumors, Excluding Breast CancerUnlock trial analytics

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

ArmTypeDescription
TKI258 (dovitinib)EXPERIMENTALdovitinib, 5 days on / 2 days off dose schedule

Interventions

NameTypeDescription
caffeineDRUGsingle dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
diclofenacDRUGsingle dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
omeprazoleDRUGsingle dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
midazolamDRUGsingle dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
TKI258DRUGdovitinib, 5 days on / 2 days off dose schedule
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about caffeine

What is caffeine used for in advanced solid tumors?

Caffeine is an investigational small molecule being studied in advanced solid tumors, excluding breast cancer. It was evaluated in a Phase 1 pharmacokinetic drug-drug interaction study in patients with these tumors. The study has been completed, and caffeine remains in clinical development for this oncology indication.

Who makes caffeine?

Caffeine is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The company sponsored a Phase 1 clinical trial of caffeine in patients with advanced solid tumors, excluding breast cancer.

What phase is caffeine in?

Caffeine is in Phase 1 clinical development for advanced solid tumors, excluding breast cancer. It has completed one Phase 1 trial, which was a pharmacokinetic drug-drug interaction study. Caffeine is investigational and has not been approved for this indication.

What clinical trials is caffeine in?

Caffeine has been studied in one clinical trial, NCT01596647, titled 'Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.' This Phase 1 study enrolled 39 patients in the United States and has been completed.

Is caffeine the same as dovitinib?

Caffeine is not the same as dovitinib. In the clinical trial NCT01596647, caffeine was studied in combination with dovitinib (TKI258) to assess a potential drug-drug interaction. Caffeine is a separate compound, and the trial evaluated how dovitinib affects caffeine's pharmacokinetics.