NCT01232829

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

October 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 26, 2014

Completed
Last Updated

November 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.8 years

First QC Date

October 30, 2010

Results QC Date

November 19, 2014

Last Update Submit

November 19, 2014

Conditions

Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Survival Rate

    The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients.

    6 months

Secondary Outcomes (2)

  • Survival

    From registration to death due to any cause, assessed up to 2 years

  • Time to Disease Progression

    From registration to documentation of disease progression, assessed up to 2 years

Study Arms (1)

Treatment (RO4929097)

EXPERIMENTAL

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy at baseline and on days 16 or 17 of course one for biomarker and other correlative studies. Blood samples may also collected at baseline and periodically during study for pharmacokinetic and angiogenesis marker studies.

Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097

Interventions

gamma-secretase/Notch signalling pathway inhibitor RO4929097DRUG

Given PO

Also known as: R4733, RO4929097
Treatment (RO4929097)

Eligibility Criteria

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

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)
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, 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)malonamide

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study met criteria to accrue 32 subjects but only 18 were enrolled. It was decided to stop further enrollment after RO4929097 was discontinued by the sponsor and was no longer a development candidate.

Results Point of Contact

Title
Dr. Wells Messersmith
Organization
University of Colorado Cancer Center
wells.messersmith@ucdenver.edu
303-724-3808

Study Officials

  • Wells Messersmith

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

May 1, 2014

Last Updated

November 26, 2014

Results First Posted

November 26, 2014

Record last verified: 2014-06

Locations

US(3)