Adenocarcinoma of the Pancreas Clinical Trial
Official title:
A Neoadjuvant Pharmacodynamic Study Of RO4929097 (RO) in Pancreas Cancer
This phase I trial is studying the side effects of RO4929097 before surgery in treating patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To evaluate the effects of neoadjuvant gamma-secretase inhibitor RO4929097 on Notch
inhibition via interrogation of Hes-1 expression in patients with pancreatic cancer.
SECONDARY OBJECTIVES:
I. To evaluate the effects of this regimen on pancreatic cancer stem cell self-renewal and
tumorigenesis as compared to pancreatic stem cells from controls (patients who do not
receive treatment).
II. To evaluate the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10 in the
absence of disease progression or unacceptable toxicity. Beginning 7 days after completion
of gamma-secretase inhibitor RO4929097, patients undergo complete resection comprising
pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy based on the
anatomic location of the cancer. Tumor tissue from biopsy and surgery and blood samples are
collected periodically for pharmacodynamic studies.
After completion of study therapy, patients are followed up every 6 months for 1 year.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01064622 -
Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00375310 -
Phase I Study of Gemcitabine, Sorafenib and Radiotherapy in Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT00095966 -
Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT00020345 -
Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas
|
Phase 2 | |
| Completed |
NCT03871959 -
Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma
|
Phase 1 | |
| Completed |
NCT03717298 -
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
|
Phase 2 | |
| Withdrawn |
NCT01401387 -
Pancreatic Enzyme Suppletion in Pancreatic Cancer
|
Phase 4 | |
| Completed |
NCT01447732 -
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01232829 -
Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
|
Phase 2 | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00735917 -
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04543071 -
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
|
Phase 2 | |
| Terminated |
NCT03490760 -
Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas
|
Phase 2 | |
| Completed |
NCT01068327 -
Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
|
Phase 1 | |
| Recruiting |
NCT05419479 -
Switch Maintenance in Pancreatic
|
Phase 1/Phase 2 | |
| Completed |
NCT01222689 -
Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00026104 -
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
|
Phase 2 | |
| Terminated |
NCT01318642 -
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
|
Phase 2 | |
| Completed |
NCT00474812 -
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
|
Phase 2 |