C-VISA BikDD: Liposome in Advanced Pancreatic Cancer
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|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Recruitment Status : Withdrawn (Stability of the DNA when admixed with the liposome failed)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 : April 11, 2019
|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|
|Estimated Study 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968604
|Study Chair:||Milind Javle, MD||M.D. Anderson Cancer Center|