Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) works in treating patients with previously treated metastatic pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell growth.

Key facts

Study ID

NCT01232829

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2010-10-01

Expected to finish

2014-05-01

Last updated by the study team

2014-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
• Not amenable to potentially curative surgical resection
• At least 1 prior regimen of chemotherapy, preferably gemcitabine-based, for metastatic disease
• Evidence of disease progression
• Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Available archived tumor tissue (baseline core biopsies or surgical tumor blocks)
• No diagnosis by fine-needle aspiration only
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (Karnofsky 70-100%)
• White blood cell count (WBC) ≥ 3,000/mm³
• Absolute neutrophil count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin normal
• Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Willingness to undergo 2 tumor biopsies, if required
• Fertile patients must use 2 forms of contraception (i.e., barrier contraception and one other method of contraception) ≥ 4 weeks prior to, during, and for ≥ 12 months after completion of therapy
• Negative pregnancy test
• Not pregnant or nursing
• Able to swallow pills
• No patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma secretase inhibitor RO4929097
• Not serologically positive for hepatitis A, B, or C
• No history of liver disease, other forms of hepatitis, or cirrhosis

Where it is running

• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Colorado — Denver, Colorado, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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