NCT01192763

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

August 31, 2010

Last Update Submit

September 27, 2013

Conditions

Adenocarcinoma of the PancreasStage IA Pancreatic CancerStage IB Pancreatic CancerStage IIA Pancreatic CancerStage IIB Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Notch activity (expression of Hes-1)

    Summarized as a binary endpoint for both the RO4929097 population and the stage-matched controls by the proportion and 95% exact binomial confidence interval.

    Up to day 3 (of course 1)

  • Frequency and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Toxicity will be determined with a 95% exact binomial confidence interval.

    Up to 1 year

Secondary Outcomes (1)

  • Proportion of cancer stem cells (CD44+, CD24+, ESA+ population of cells) self-renewal and tumorigenesis as measured by FACS

    Up to day 3 (of course 1)

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097Other: laboratory biomarker analysisOther: pharmacological studyProcedure: neoadjuvant therapyProcedure: therapeutic conventional surgery

Interventions

gamma-secretase/Notch signalling pathway inhibitor RO4929097DRUG

Given orally

Also known as: R4733, RO4929097
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I
neoadjuvant therapyPROCEDURE
Arm I
therapeutic conventional surgeryPROCEDURE
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • T1-3, N0-1, and M0 disease
  • Surgically resectable disease confirmed by a surgeon experienced in pancreatic surgery
  • No borderline resectable disease defined as any of the following:
  • Tumors with severe unilateral or bilateral SMV/portal involvement impingement
  • Abutment (or) encasement of hepatic artery
  • SMA or celiac encasement (or) presence of SMV occlusion by tumor
  • No metastatic disease
  • ECOG performance status 0-1
  • Life expectancy \> 6 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 mg/dL
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tower Cancer Research Foundation

Beverly Hills, California, 90211-1850, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 60702, United States

Location

Fort Wayne Medical Oncology and Hematology Inc - State Boulevard

Fort Wayne, Indiana, 46845, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamideNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Edward Kim

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2012

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

US(6)