Status and phase
Conditions
Treatments
About
To evaluate the safety, tolerability, and efficacy of TTI-101 given in combination with Stereotactic Body Radiation Therapy (SBRT) in borderline resectable pancreatic ductal adenocarcinoma.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males:
Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
Females:
Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
Exclusion criteria
John's wort, kava, ephedra (Ma Huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Participants should stop using herbal medications 7 days prior to the first dose of study treatment.
Note: Participants with chronic HCV infection are allowed to enroll into the study but do not have a defined maximum viral load requirement for study entry. Participants with both HBV and HCV infection are excluded unless they have negative HCV RNA.
History of malignancy other than PDAC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate participation in the clinical study, or compromise compliance with the protocol such as:
Prior treatment for pancreatic cancer in the past 2 years and outside of the induction chemotherapy received for the current diagnosis.
Measurable distant metastases on re-staging imaging post chemotherapy that meets RECIST1.1 criteria.
A history of other malignancy ≤ 3 years previous except for basal cell or squamous cell carcinoma of the skin which were treated with local resection only, or carcinoma in situ of the cervix.
Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device overlapping with study treatments within 3-6 months preceding diagnosis at the discretion of the PI.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101.
Primary purpose
Allocation
Interventional model
Masking
35 participants in 2 patient groups
Loading...
Central trial contact
Saralina Nguyen
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal