drugset / Trial / NCT02535312

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin

NCT02535312

Phase 1/2 Active not recruiting 30 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.

Timeline

Start
2016-03-08
Primary completion
2022-12-31
Completion
2026-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified Intravenous
Subject Methoxyamine Small molecule Oral
Background Pemetrexed Small molecule Intravenous