C-VISA BikDD: Liposome in Advanced Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00968604|
Recruitment Status : Withdrawn (Stability of the DNA when admixed with the liposome failed)
First Posted : August 31, 2009
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Genetic: BikDD Nanoparticle||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2017|
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.
- Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer [ Time Frame: Weekly during 28 day cycles ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968604
|Study Chair:||Milind Javle, MD||M.D. Anderson Cancer Center|