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GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

NCT00878163 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-13

No results posted yet for this study

Summary

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.

Conditions

  • Adult Solid Neoplasm
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Recurrent Pancreatic Carcinoma
  • Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

DRUG

Erlotinib Hydrochloride

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Vismodegib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Charles Erlichman · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-01-22
Completion
2027-03-06

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 NCT00878163 on ClinicalTrials.gov