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NCT03203525 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer
A Phase 1 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm in the Liver, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT03203525: Active Phase 1 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm in the Liver, sponsored by M.D. Anderson Cancer Center.
NCT03203525 is a Phase 1 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm in the Liver that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 38 participants, below the 174-participant average among 16 other Advanced Malignant Neoplasm trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03203525, a Phase 1 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm in the Liver, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of combination chemotherapy and bevacizumab, and to see how well they work with the NovoTTF-100L(P) system in treating participants with cancer that has come back or does not respond to treatment and has spread to the liver. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, pegylated liposomal doxorubicin hydrochloride, and temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The NovoTTF-100L(P) system is a portable device that uses electrical fields to stop the growth of tumor cells. Giving combination chemotherapy and monoclonal antibody therapy while using the NovoTTF-100L(P) system may kill more tumor cells.
Primary Outcome
Descriptive statistics will be provided on the grade and type of toxicity by dose level.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- BIOLOGICAL Bevacizumab
- DRUG Pegylated Liposomal Doxorubicin Hydrochloride
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-06-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03203525 still lists
NCT03203525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 174-participant average among 16 other Advanced Malignant Neoplasm trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Advanced Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT03203525 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03203525 about?
NCT03203525 is a clinical study titled "Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer". This phase I trial studies the side effects and best dose of combination chemotherapy and bevacizumab, and to see how well they work with the NovoTTF-100L(P) system in treating participants with cancer that has come back or does not respond to treatment and has spread to the liver. Drugs used in che...
What is the current status of trial NCT03203525?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2020-06-23. Estimated completion is 2026-12-31.
What conditions does trial NCT03203525 study?
This clinical trial studies the following conditions: Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm in the Liver, Refractory Malignant Neoplasm, Colorectal Carcinoma Metastatic in the Liver.
What interventions are being tested in trial NCT03203525?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Bevacizumab (BIOLOGICAL), Pegylated Liposomal Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03203525?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03203525 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 NCT03203525's enrollment target sits among peer trials
38 16th of 16 higher than 1 of 16 other Advanced Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant 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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