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Anti-metabolites
nab paclitaxel for Pancreatic Adenocarcinoma
Phase 1
Waitlist Available
Led By Vincent J Picozzi, MD
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This study is evaluating whether a combination of drugs may help improve outcomes for individuals with cancer.
Eligible Conditions
- Pancreatic Adenocarcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment safety as assessed by CTCAE v4.03
Secondary outcome measures
Overall survival
Progression free survival (PFS)
Response rate
Side effects data
From 2010 Phase 2 trial • 63 Patients • NCT0062949976%
Neutrophils
49%
Alopecia
41%
Fatigue
33%
Arthralgia/Myalgia
22%
Hemoglobin
22%
Nausea
13%
Rash
11%
Vomiting
8%
Neuropathy
8%
Diarrhea
2%
Mental Status
2%
Hemorrhage - GI
2%
Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention
Trial Design
2Treatment groups
Experimental Treatment
Group I: Resectable patientsExperimental Treatment5 Interventions
Gemcitabine and Nab-Paclitaxel Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle. Followed by nal-IRI (ONIVYDE®) 70 mg/m^2 followed by leucovorin 400 mg/m^2 followed by 5FU 2400 mg/m^2 on days 1, 15 of the 28 day cycle.
Group II: Borderline resectable patientsExperimental Treatment5 Interventions
Gemcitabine and Nab-Paclitaxel Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle. Followed by nal-IRI (ONIVYDE®) 70 mg/m^2 followed by leucovorin 400 mg/m^2 followed by 5FU 2400 mg/m^2 on days 1, 15 of the 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Irinotecan
FDA approved
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
Benaroya Research InstituteLead Sponsor
45 Previous Clinical Trials
11,287 Total Patients Enrolled
Vincent J Picozzi, MDPrincipal InvestigatorVirginia mason medical Center
1 Previous Clinical Trials
21 Total Patients Enrolled
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