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MEK Inhibitor

Trametinib for Ovarian Cancer

Phase 2 & 3

Waitlist Available

Led By David M Gershenson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Discontinue other prior therapy directed at the malignant tumor, including chemotherapy and radiation therapy, at least 4 weeks prior to registration

Patients must have a GOG performance status of 0 or 1

Must not have

Patients who require use of a concomitant medication that can prolong the QT interval

Patients with a history or current evidence/risk of retinal vein occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from study entry to time of death or date of last contact, an average of 29 months for arm a and 37 months for arm b

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well trametinib works compared to standard treatments for ovarian or peritoneal cancer that has come back or spread to other parts of the body.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Trametinib may cause side effects such as skin rash, diarrhea, fatigue and elevated blood pressure. It can also lead to more serious conditions like heart problems or eye issues such as retinal vein occlusion. Standard treatment side effects vary depending on the drug used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My low-grade serous ovarian or peritoneal cancer has come back.

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I can take pills and have no major stomach or intestine problems.

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My side effects from previous treatments are mild, except for hair loss.

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My heart pumps blood normally.

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My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.

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My cancer can be measured by scans and meets the size requirements.

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My cancer returned or worsened after platinum-based chemotherapy.

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My low-grade serous ovarian or peritoneal cancer has come back.

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My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.

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My cancer is confirmed as low-grade serous carcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history or risk of blocked blood vessels in my eye.

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I am not taking any medication that is not allowed in the study.

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I have cancer that has spread to my brain or spinal cord.

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I have a condition affecting how my body absorbs pills.

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I have had interstitial lung disease or pneumonitis.

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My cancer has not worsened after radiation on a key tumor.

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I am not pregnant or breastfeeding.

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I have hepatitis B, hepatitis C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from study entry to time of death or date of last contact, an average of 29 months for arm a and 37 months for arm b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from study entry to time of death or date of last contact, an average of 29 months for arm a and 37 months for arm b

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study entry to time of death or date of last contact, an average of 29 months for arm a and 37 months for arm b for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Incidence of Adverse Events (AEs)

Objective Tumor Response Rate (Complete Response and Partial Response)

Overall Survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (trametinib)Experimental Treatment2 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 Control7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

0 / 21Eligibility criteria met