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PHY906

Phase 1

Pancreatic Cancer | Small molecule | Other |Roche Holding AG|Last Updated: Mar 27, 2015

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2006

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

PHY906 · 1 trial · 1 indication

Phase 1 1
NCT00411762A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic CarcinomaPancreatic Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Median Progression Free Survival
Up to 100 weeks

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Endpoints

Median Overall Survival
Up to 100 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PHY906 AdministrationEXPERIMENTALPHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle

Interventions

NameTypeDescription
CapecitabineDRUG -
PHY906DRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Men or women ≥18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who h...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 177 trials