Study on Re-sensitizing Carboplatin-resistant Ovarian Cancer with Kinase Inhibition of FAK
Sponsor: Michael McHale
ClinicalTrials ID:NCT03287271
This clinical trial is exploring a new treatment combination for ovarian cancer that has become resistant to carboplatin. The study will test if adding an experimental drug, VS-6063, to standard chemotherapy drugs carboplatin and paclitaxel can help reduce cancer cells.
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Program Overview
The goal of this study is to find out if a new combination of treatments can help patients with ovarian cancer that has stopped responding to carboplatin. The treatment includes an experimental drug called VS-6063, along with the standard chemotherapy drugs carboplatin and paclitaxel. Researchers want to see if this combination is safe and if it can effectively reduce cancer cells in the body. Participants will take VS-6063 orally and receive carboplatin and paclitaxel through infusions. While carboplatin and paclitaxel are approved for treating ovarian cancer, VS-6063 is still experimental and not yet approved by the FDA for cancer treatment.
Description
The study is testing a new treatment approach for ovarian cancer that has become resistant to carboplatin. It combines an experimental drug, VS-6063, with two chemotherapy drugs, carboplatin and paclitaxel. The aim is to see if this combination is safe and can reduce cancer cells. Participants will take VS-6063 by mouth and receive carboplatin and paclitaxel through infusions. While carboplatin and paclitaxel are approved for ovarian cancer, VS-6063 is still experimental. The study will help determine if this new combination can be a more effective treatment option for patients.
Eligibility Criteria
Inclusion Criteria
- Have recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer diagnosed within 6 months after finishing the last platinum-based chemotherapy.
- Have specific types of cancer cells, such as serous adenocarcinoma or clear cell adenocarcinoma.
- Have had one previous platinum-based chemotherapy treatment for the primary disease.
- Have not received more than two total previous lines of chemotherapy for recurrent or persistent disease.
- May have had one additional non-chemotherapy treatment for recurrent or persistent disease, such as hormone therapy or monoclonal antibodies.
- Women of childbearing age must have a negative pregnancy test and use effective birth control.
- Have adequate bone marrow, kidney, liver, and nerve function.
- Have recovered from recent surgery, radiation, or chemotherapy, with any side effects being mild.
- Be free of active infections needing antibiotics, except for simple urinary tract infections.
- Any hormone therapy for the cancer must be stopped at least one week before joining the study.
Exclusion Criteria
- Have ovarian, fallopian tube, or primary peritoneal cancer that does not respond to platinum-based treatments.
- Have another primary or previous cancer diagnosed within 5 years, except for treated non-melanoma skin cancer.
- Are currently receiving chemotherapy or radiation therapy.
- Have been treated with kinase inhibiting agents before.
- Have a history of gastrointestinal issues like fistulas, bleeding, or ulcers.
- Are pregnant or breastfeeding.
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