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ACTIVE NOT RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Vismodegib
  • DRUG Gemcitabine Hydrochloride
  • OTHER Diagnostic Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride

Study Locations (4)

Florida

  • Mayo Clinic in Florida — Jacksonville
  • Orlando Health Cancer Institute — Orlando

Arizona

  • Mayo Clinic in Arizona — Scottsdale

Minnesota

  • Mayo Clinic in Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2009-03-31
Est. Completion 2027-03-06
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00878163

The ClinicalTrials.gov registry entry for NCT00878163 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Vismodegib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00878163 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Florida, Arizona, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00878163 about?

NCT00878163 is a clinical study titled "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". 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, s...

What is the current status of trial NCT00878163?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2009-03-31. Estimated completion is 2027-03-06.

What conditions does trial NCT00878163 study?

This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Adult Solid Neoplasm, Stage IV Pancreatic Cancer AJCC v6 and v7, Recurrent Pancreatic Carcinoma, Pancreatic Acinar Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00878163?

The interventions under investigation include: Vismodegib (DRUG), Gemcitabine Hydrochloride (DRUG), Diagnostic Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00878163?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00878163 being conducted?

This trial has 4 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial