A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

NCT ID: NCT00711191

Last Updated: 2013-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-01-31

Brief Summary

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This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.

Detailed Description

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Conditions

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Pancreatic Neoplasm

Keywords

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pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Group Type EXPERIMENTAL

monoclonal antibody

Intervention Type BIOLOGICAL

CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles

chemotherapy

Intervention Type DRUG

gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles

Interventions

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monoclonal antibody

CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles

Intervention Type BIOLOGICAL

chemotherapy

gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1st-line surgically incurable cancer of the pancreas
* ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion Criteria

* Previous systemic therapy for pancreas cancer
* History of cancer-associated blood clots
* History of autoimmune disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Beatty GL, Chiorean EG, Fishman MP, Saboury B, Teitelbaum UR, Sun W, Huhn RD, Song W, Li D, Sharp LL, Torigian DA, O'Dwyer PJ, Vonderheide RH. CD40 agonists alter tumor stroma and show efficacy against pancreatic carcinoma in mice and humans. Science. 2011 Mar 25;331(6024):1612-6. doi: 10.1126/science.1198443.

Reference Type DERIVED
PMID: 21436454 (View on PubMed)

Related Links

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Other Identifiers

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A5021005

Identifier Type: -

Identifier Source: org_study_id