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Patupilone and Omeprazole

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 8, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Patupilone and Omeprazole · 1 trial · 1 indication

Phase 1 1
NCT00420615Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced MalignanciesSolid Tumors
COMPLETED34 Analytics
PHASE1COMPLETED
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Solid Tumors
NCT0042061534
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Study Endpoints

Primary Endpoints

To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)

Secondary Endpoints

To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.
at each visit (week 1, week 2, week 5, and end of study)
To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.
at each visit (week 1, week 2, week 5, and end of study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Patupilone and OmeprazoleEXPERIMENTALpatupiloe + omeprazole
patupilone + midalzolamEXPERIMENTALpatupilone + midalzolam

Interventions

NameTypeDescription
Patupilone and OmeprazoleDRUG -
Patupilone + MidalzolamDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male or female patients 18 years or older * Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist * Life expectancy of 3 months or more * Patients with adequate hematologic parameters Ex...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about Patupilone and Omeprazole

What is Patupilone used for?

Patupilone is an investigational small molecule being studied in oncology for several advanced cancers, including metastatic hormone refractory prostate cancer, advanced solid tumors, brain metastasis, carcinoma, and non-small-cell lung cancer. It is developed by Novartis AG and is currently in Phase 1 clinical development.

What does Patupilone target?

Patupilone is a small molecule in oncology. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not detailed here. It is being investigated for its potential effects in advanced malignancies and solid tumors.

Who makes Patupilone?

Patupilone is developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials for various oncology indications.

What phase is Patupilone in?

Patupilone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials for Patupilone have been completed, with no active trials currently ongoing.

What clinical trials is Patupilone in?

Patupilone has completed four Phase 1 clinical trials: NCT00420524 and NCT00421044 studied the drug in patients with advanced solid tumors and varying degrees of hepatic function; NCT00426140 examined its pharmacokinetics after a single intravenous administration; and NCT00448396 evaluated its effects on warfarin pharmacokinetics and pharmacodynamics in advanced malignancies.

Is Patupilone the same as epothilone B?

Patupilone is also known as epothilone B, a natural product derived from the myxobacterium Sorangium cellulosum. It is being developed by Novartis AG as an anticancer agent and is currently in Phase 1 clinical trials for advanced solid tumors and other malignancies.