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Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas

NCT01088815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-04-26

Study results available
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Summary

This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression free survival in patients with metastatic adenocarcinoma of the pancreas treated with a hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and nab-Paclitaxel).

Conditions

Interventions

DRUG

Gemcitabine, nab-Paclitaxel, GDC-0449

1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Daniel Laheru, MD · Sidney Kimmel Comprehensive Cancer Center JHMI

  • Ana De Jesus-Acosta, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-17
Primary Completion
2017-12-01
Completion
2018-02-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088815 on ClinicalTrials.gov