drugset / Trial / NCT02101788

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788

Phase 2/3 Completed 260 enrolled National Cancer Institute (NCI) NRG Oncology · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This phase II/III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen, paclitaxel, pegylated liposomal doxorubicin, or topotecan in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back (recurrent), become worse (progressive), or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.

Timeline

Start
2014-04-11
Primary completion
2019-04-04
Completion
2025-10-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 40 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Comparator Letrozole Other / unclassified 2.5 mg Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator Tamoxifen Small molecule 20 mg Oral
Comparator Topotecan Small molecule 4 mg/m2 Intravenous
Subject Trametinib Small molecule 2 mg Oral