C-VISA BikDD: Liposome in Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest tolerable dose of BikDD nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety of this drug will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Open-Label Dose Escalation Study to Assess the Safety and Tolerability of the BikDD Nanoparticle in Patients With Advanced Pancreatic Cancer|
- Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer [ Time Frame: Weekly during 28 day cycles ] [ Designated as safety issue: No ]The maximum tolerated dose (MTD) is defined as the maximal achievable dose level at which < 1/6 enrolled patients experiences dose-limiting toxicity.
- Dose-Limiting Toxicity (DLT) [ Time Frame: Continuously during 28 day cycles ] [ Designated as safety issue: No ]
Dose-limiting toxicity (DLT) defined as:
Any ≥ grade 3 hematologic and non-hematologic toxicity as per NCI CTCAE v. 4.0 with the following exceptions:
- Grade 3 or 4 lymphopenia unless persistent for >14 days or associated with single oral temperature of >38.3°C (101°F) or temp > 38°C (100.4°F) measured on two separate occasions one hour apart.
- Adverse events (Grade 3 or greater) for which a clinical cause unrelated to study drug is evident will not be considered DLTs. These will include: obstructive jaundice from stent occlusion, narcotic-induced constipation if symptom is present prior to study enrollment, anorexia or cachexia if present prior to study enrollment.
- Delay of Dose > 14 days due to toxicity.
|Study Start Date:||July 2014|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: BikDD Nanoparticle
BikDD Nanoparticle starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
Genetic: BikDD Nanoparticle
Starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
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|Study Chair:||Milind Javle, MD||UT MD Anderson Cancer Center|