case-study-of-metastatic-colorectal-cancer

The CRCs of Clinimed Lifesciences have conducted the BABE study of an Oral Investigational Product which is used to treat colorectal cancer in Metastatic colorectal patients at Netaji Shubas Chandra Bose Cancer Research Institute Kolkata under Dr. Bodhisatta Roy. 

It is multiple dose crossover Bioavailability/Bioequivalence study of Investigational product(Trifluridin+Tipiracil) against marketed Reference drug. As per protocol 36 patients can be recruited all over India. The study period for these study was 3 months.

Among 36 patients we have screened 21 patients and recruited 16 patients. We can only treated those patients who has already treated with first and second line standard care chemotherapy.

For these study, screening period was 14 days. Within 14 days we have to randomized the patients if he/she can meet all the inclusion and exclusion criteria. In these study each cycles have 2 periods and each period has 5 days. Duration between each cycle is 14 days. 

On the days of Oral chemo(day 1 to day 5) we gave standard meal to the patients on morning and evening half an hour before IMP taking time. Dipped egg cheese sandwich has given to the patient.

As it is BA/BE study, our phlebotomist has collected pK samples of patients for analysis. From day 1 to day 4 morning and evening pK samples are collected half an hour before standard meal . On day 5 pK samples collection time points are  0.50, 1.00, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00.

Compassionate medicine has given to the patient after completion of their certain cycles. 

Study was end on 31st  of August and the study has been submitted to USFDA. The whole study is conducted and completed by CLINIMED LIFESCIENCES PVT. LTD.