Phase II Preventing Mesothelioma Progression
Status: Terminated
Type: Pleural Mesothelioma
In a phase I trial anetumab ravtansine proved to have amazing results. Most of the patients treated in phase I were able to control their disease. Now, researchers are performing a phase II trial to test anetumab ravtansine as as second line treatment.
Anetumab Ravtansine as a Second Line Treatment
This is a phase II trial to test anetumab ravtansine, also known as BAY 94-9343, for its ability to prevent mesothelioma progression. This trial may be able to help patients who show an overexpression of the protein mesothelin. Anetumab ravtansine can target mesothelioma cells specifically to keep the cancer from growing or spreading.
Medications Used In This Trial
Anetumab Ravtansine – This drug is a targeted mesothelioma treatment. It focuses on attacking cells that overexpress mesothelin. Mesothelin is a protein that can be found in healthy tissue but is found in much higher quantities in the tumor cells of certain cancers like mesothelioma. Targeted treatments are often prefered because they specialize in attacking cancerous cells making them safer for healthy cells.
Vinorelbine – This drug is also called Navelbine. It is derived from the periwinkle plant. It is a chemotherapy drug given intravenously to treat certain types of cancer. Cancer cells divide without the control that normal cells have, so they grow quickly. Chemotherapy drugs work to stop cell division and work best on rapidly dividing cells like cancer cells.
In phase I of the trial, anetumab ravtansine proved to be incredibly effective, especially on patients who had already received standard chemotherapy without result. 10 of the patients in the phase I trial received anetumab ravtansine as a second line treatment. 5 out of 10 had tumor shrinkage and 4 out of 10 kept their disease stable.
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Reasons to consider this trial:
- Offers second line treatment for patients who have already received standard treatment
- Available in locations around the country and world
- May help to curb disease progression
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Bayer
SponsorPhase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
Unofficial TitleNCT02610140
Clinical Trial IDPleural
Mesothelioma183
ParticipantsLocations
- Multiple 75+
What to Expect:
The trial has two arms. In the experimental arm, patients will receive anetumab ravtansine to test its effects on mesothelioma. In the comparator arm, patients will receive vinorelbine so that researchers can compare the results of the experimental arm to another drug. Patients will either receive anetumab ravtansine every three weeks or vinorelbine every week.
Blood tests and tumor assessments will be performed throughout the treatment to monitor the patient’s health and progress. Treatment will continue until the patient has disease progression or until they meet other criteria to be able to withdraw from the study. Efficacy will be measured by the rate of progression free survival.
Experimental Arm
Patients in the experimental arm will receive anetumab ravtansine as an IV infusion for 1 hour every 3 weeks. The treatment will continue until the patient has disease progression or withdraws for another reason.
Comparator Arm
Patients in the active comparator arm of the experiment will receive vinorelbine through an IV for 6 to 10 minutes weekly. Treatments will continue until the patient has disease progression or withdraws from the trial.
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Who Is This Trial For?
This clinical trial is available to patients with malignant pleural mesothelioma who have tried standard first line chemotherapy but did not see results.
General eligibility criteria includes:
- Diagnosed pleural mesothelioma
- Overexpression of the mesothelin protein
- Did not improve after receiving standard chemotherapy
- Healthy heart
Locations
There are 76 different locations around the world participating in this clinical trial. Of those 76, there are 19 locations spread throughout the United States.
There are locations in these states: California, Colorado, Connecticut, Florida, Illinois, Louisiana, Maryland, Michigan, Minnesota, New York, North Carolina, Ohio, Pennsylvania, and Texas.
Enrolling in This Trial
In phase I, anetumab ravtansine had amazing results on the participants in the trial. Now, phase II is recruiting pleural mesothelioma patients. Contact us for more information about participating in this clinical trial or others. Get connected to this clinical trial today.
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