p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

December 20, 2016

Primary Completion Date

October 25, 2017

Study Completion Date

October 30, 2017

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Tetrahydrouridine

"Starting dose is by weight:~THU is supplied as 250 mg/capsule Weight 40-60kg = 2 capsules of Tetrahydrouridine. Weight 61-80kg = 3 capsules of THU. Weight 81-100kg or higher = 4 capsules of THU.~Timing between THU and Dec, Frequency of administration: Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days. Treatment on protocol monitoring continues for 52 weeks, however, subjects will have the option to continue beyond this period if it judged to be in their interests."

DRUG

Decitabine

"Starting dose is by weight:~DEC is supplied as 5 mg/capsule. Weight 40-60kg = 2 capsules of Decitabine. DEC capsules are ingested \~60 minutes after THU capsules. Weight 61-80kg = 3 capsules of DEC. DEC capsules are ingested \~60 minutes after THU capsules. Weight 81-100kg or higher = 4 capsules of DEC. DEC capsules are ingested \~60 minutes after THU capsules.~Timing between THU and Dec, Frequency of administration: Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days. Treatment on protocol monitoring continues for 52 weeks, however, subjects will have the option to continue beyond this period if it judged to be in their interests."

Trial Locations (2)

44106

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Yogen Saunthararajah

OTHER

NCT02847000 - p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer | Biotech Hunter | Biotech Hunter