Status:
ACTIVE_NOT_RECRUITING
A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
Brief Summary
This is a single-center, pilot study evaluating the addition of Ciprofloxacin (study drug) to standard-of-care gemcitabine and nab-paclitaxel chemotherapy in treatment-naïve metastatic PDAC patients. ...
Detailed Description
Oral ciprofloxacin (study drug) will be administered twice a day throughout each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy. The patient will start taking ciprofloxacin from the eveni...
Eligibility Criteria
Inclusion
- Signed informed consent. Written informed consent must be obtained prior to performing any study-related procedures.
- Age ≥ 21 years
- Histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic pancreatic adenocarcinoma planned to commence on gemcitabine and nab-paclitaxel chemotherapy.
- Patient must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)
- Life expectancy \>3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- CrCl ≥ 30 ml/min
Exclusion
- Known hypersensitivity or allergy to ciprofloxacin or other quinolones
- On tizanidine or theophylline and unable to stop these medication
- Known QTc prolongation (QTc \>500 msec) or torsade de pointes
- Presence of Clostridium difficile-associated diarrhea or colitis
- Known history of myasthenia gravis
- Known G6PD deficiency
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04523987
Start Date
February 22 2019
End Date
February 1 2027
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National University Hospital
Singapore, Singapore