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NCT01787500 · ClinicalTrials.gov registry record · Phase 1
Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Colorectal Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01787500: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Colorectal Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT01787500 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Colorectal Cancer AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 33 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01787500, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Colorectal Cancer AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of vemurafenib when given together with cetuximab and irinotecan hydrochloride in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Vemurafenib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib with cetuximab and irinotecan hydrochloride may be a better treatment for solid tumors.
Primary Outcome
Descriptive statistics will be provided on the grade and type of toxicity by dose level.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Irinotecan Hydrochloride
- DRUG Vemurafenib
- OTHER Pharmacological Study
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-02-15 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT01787500 still lists
NCT01787500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (84% lower).
The record links to 7 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT01787500 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01787500 about?
NCT01787500 is a clinical study titled "Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of vemurafenib when given together with cetuximab and irinotecan hydrochloride in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Vemurafenib and irinotecan hydrochloride may st...
What is the current status of trial NCT01787500?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-02-15. Estimated completion is 2026-03-31.
What conditions does trial NCT01787500 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Unresectable Solid Neoplasm.
What interventions are being tested in trial NCT01787500?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Irinotecan Hydrochloride (DRUG), Vemurafenib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01787500?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01787500 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01787500's enrollment target sits among peer trials
33 77th of 92 higher than 16 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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.
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