Assessment of Drug Efficacy in a Survival Study

  • 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.


  • 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.

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