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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). 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.
Primary Outcome
MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib
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 |
What the finished NCT00769483 record still lists
NCT00769483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT00769483 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00769483's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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
- NCT04966481 · 81 participants · Phase 3
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
- NCT05109429 · 81 participants · NA
Developing a Clinical Outcome Assessment for Opioid Craving
- NCT05112601 · 81 participants · Phase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
- NCT05305911 · 81 participants · Phase 2
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
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