Assessment of Drug Efficacy in a Survival Study
LASP-06
LASP-07
LASP-10
LASP-11
- Evaluates drug efficacy in a three, four, or five arm study format.
- Includes cryopreserved tissues and blood plasma.
- Includes quantitative assessment of up to five informative biomarkers by immunohistochemistry.
- Available in Kras/p53 pancreatic ductal adenocarcinoma or Kras/p53 non-small cell lung cancer mice.
- Includes sufficient basic consultation with a subject matter expert.
Process
- Induce breed 50 KPC animals with the intent of generating a cohort of 40 animals with confirmed tumor-load matching the following enrollment criteria:
- Female mice are considered eligible for enrollment when ultrasound examination within 24 hours reveals 1 or 2 tumors, with the largest size being 6–11 mm and a combined tumor volume of 100–350 mm3.
- Animals with three or more tumors per organ; cystic tumors; signs of intestinal, pancreatic, or gall bladder duct occlusions; or otherwise moribund/showing signs of dilapidation will not be included in the study.
- Compare four treatments (vehicle and compound of interest at two different concentrations).
- Allow mice to progress to study end-points, defined as either 20 percent weight loss or displaying recognizable signs of morbidity, general lack of reflexes, abnormal posture, or visible respiratory distress.
- Monitor mice frequently once started on treatments, including:
- Daily observations by trained personnel
- Recording of daily weights for all mice enrolled in the study
- Monitoring for signs of abdominal/ascitic fluid accumulation
- Observations of tumor progression by size/volume measurement using ultrasound imaging (two weekly sessions or less frequently as directed by study design and/or drug administration regimen)
- Weekly mandibular blood collection (up to 100µl of whole blood) and storage for subsequent biomarker assessment
- Process animals reaching study endpoints (or if found deceased) for necropsy and blood collection (if “warm” necropsy) to prepare multi-organ blocks/tissue slides for pathology evaluation and biomarker assessment.
- If requested, the Laboratory Animal Sciences Program will prepare flash-frozen samples of pancreatic tumor, adjacent non-pathologic pancreas, and other organs.
- The estimated completion time for this service is 10 months.
Group | Treatment | Dose/Schedule | Collection at | n |
---|---|---|---|---|
1 | Vehicle | TBD* IP, q4d x 8 | Endpoint, X* hrs post-treatment | 10 |
2 | AS1 | TBD* IP, q4d x 8 | Endpoint, X* hrs post-treatment | 15 |
3 | AS2 | TBD* IP, q4d x 8 | Endpoint, X* hrs post-treatment | 15 |
TBD* - Dosing concentrations will be provided prior to initiation of study by the requestor.