RO4929097 Before Surgery in Treating Patients With Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byEdward Kim

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Edward Kim

Principal Investigator

University of Chicago Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed pancreatic adenocarcinoma

T1-3, N0-1, and M0 disease

Surgically resectable disease confirmed by a surgeon experienced in pancreatic surgery

See 7 more

Treatment Details

Interventions

RO4929097 (Gamma-secretase/Notch Signaling Pathway Inhibitor)
Therapeutic Conventional Surgery (Surgery)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Arm IExperimental Treatment5 Interventions

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.