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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 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.

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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.

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

FieldValue
Enrollment Target 38 participants
Start Date 2020-06-23
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT03203525

The ClinicalTrials.gov registry entry for NCT03203525 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 16 other Advanced Malignant Neoplasm trials with a reported enrollment target (78% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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