Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00769483 · ClinicalTrials.gov registry record · Phase 1
MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT00769483: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00769483 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 81 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769483, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
Objectives: Primary Objectives: * Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose. * Phase II: * Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b) gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib. * Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II expansion cohort. Secondary Objectives: * Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib. * Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells. * To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical endpoints of this study, including OS, ORR and PFS.
Interventions
- DRUG Gemcitabine
- DRUG Erlotinib
- DRUG MK-0646
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2008-11-13 |
| Est. Completion | 2020-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00769483
The ClinicalTrials.gov registry entry for NCT00769483 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT00769483 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00769483 about?
NCT00769483 is a clinical study titled "MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer". Objectives: Primary Objectives: * Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose. * Phase II: * Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b) gemcitabine plus...
What is the current status of trial NCT00769483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2008-11-13. Estimated completion is 2020-09-01.
What interventions are being tested in trial NCT00769483?
The interventions under investigation include: Gemcitabine (DRUG), Erlotinib (DRUG), MK-0646 (DRUG).
Who is sponsoring clinical trial NCT00769483?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.