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NCT00878163 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Pancreatic Ductal Adenocarcinoma and Adult Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 4
- Study locations
NCT00878163 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Adult Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT00878163, a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Adult Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 4
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-03-31 |
| Est. Completion | 2027-03-06 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (91% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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.
NCT00878163 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Florida, Arizona, Minnesota.
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.
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).
Who is sponsoring clinical trial NCT00878163?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
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