Trametinib for Ovarian Cancer

Recruiting at 583 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

David M Gershenson

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with recurrent or progressive low-grade ovarian cancer or peritoneal cavity cancer who have previously undergone at least one platinum-based chemotherapy. They must not have received certain inhibitor therapies, be able to swallow oral medication, and meet specific health criteria including organ function tests. Pregnant women, nursing mothers, and those with serious medical risks are excluded.

Inclusion Criteria

I stopped my cancer hormone therapy at least a week ago.

I stopped any cancer treatments like chemo or radiation 4 weeks ago.

I am following the birth control and pregnancy guidelines for Trametinib.

Exclusion Criteria

I have not been treated with MEK, KRAS, or BRAF inhibitors.

I need medication that can affect my heart's rhythm.

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to DMSO, or to Cremophor EL

Treatment Details

Interventions

• Trametinib (MEK Inhibitor)

Trial Overview The effectiveness of trametinib is being compared to standard treatments (letrozole, tamoxifen, paclitaxel, pegylated liposomal doxorubicin hydrochloride or topotecan) in this phase II/III trial. Trametinib aims to inhibit enzymes needed for tumor cell growth and its performance will be measured against existing therapies.

Participant Groups

Group I: Arm B (trametinib) Experimental Treatment 2 Interventions

Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (letrozole, tamoxifen, paclitaxel, PLD, topotecan) Active Control 7 Interventions

Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B.

Trametinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Mekinist for:

• Melanoma
• Non-small cell lung cancer

Approved in Japan as Mekinist for:

• Melanoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+