Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Pancreatic Ductal Adenocarcinoma and Adult Solid Neoplasm, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT will be defined as an adverse event, according to CTCAE version 3.0, attributed (definitely, probably, or possibly to the study treatment.
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 |
What the registry record for NCT00878163 still lists
NCT00878163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pancreatic Ductal Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00878163's enrollment target sits among peer trials
55 55th of 84 higher than 30 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
-
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
RECRUITING · Phase 1
-
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI