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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My low-grade serous ovarian or peritoneal cancer has come back.
Select...
I can take pills and have no major stomach or intestine problems.
Select...
My side effects from previous treatments are mild, except for hair loss.
Select...
My heart pumps blood normally.
Select...
My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.
Select...
My cancer can be measured by scans and meets the size requirements.
Select...
My cancer returned or worsened after platinum-based chemotherapy.
Select...
My low-grade serous ovarian or peritoneal cancer has come back.
Select...
My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.
Select...
My cancer is confirmed as low-grade serous carcinoma.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Incidence of Adverse Events (AEs)
Objective Tumor Response Rate (Complete Response and Partial Response)
Overall Survival
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,592 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,893 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
David M GershensonPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
2,050 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I can understand and sign the consent form.I am fully active or restricted in physically strenuous activity but can do light work.It has been over 4 weeks since my last major surgery.I have not been treated with MEK, KRAS, or BRAF inhibitors.My low-grade serous ovarian or peritoneal cancer has come back.I need medication that can affect my heart's rhythm.My cancer can be measured by scans and meets the size requirements.My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.I have a history or risk of blocked blood vessels in my eye.You cannot have taken any experimental drugs within 28 days before starting trametinib treatment or any standard medications.I can take pills and have no major stomach or intestine problems.My side effects from previous treatments are mild, except for hair loss.My heart pumps blood normally.My initial diagnosis was serous borderline ovarian or peritoneal carcinoma, and it has recurred as low-grade serous carcinoma.My cancer returned or worsened after platinum-based chemotherapy.My low-grade serous ovarian or peritoneal cancer has come back.It has been over 4 weeks since my last major surgery.My cancer is confirmed as low-grade serous carcinoma.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I am not taking any medication that is not allowed in the study.I have cancer that has spread to my brain or spinal cord.I have a condition affecting how my body absorbs pills.I have had interstitial lung disease or pneumonitis.My cancer has not worsened after radiation on a key tumor.You cannot have already received all of the standard treatments available for your condition.I stopped any hormone treatments for my cancer a week ago.I have had multiple previous treatments for my condition.I am postmenopausal and meet the requirements for Letrozole treatment.I have a history of heart problems or am at risk for heart disease.My cancer is confirmed as low-grade serous carcinoma by a recent pathology review.You cannot have already received all of the standard treatment options available for your condition.I am not pregnant or breastfeeding.I have hepatitis B, hepatitis C, or HIV.I have received treatment for my condition before.I have had cancer at another site but it's an exception.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (letrozole, tamoxifen, paclitaxel, PLD, topotecan)
- Group 2: Arm B (trametinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being signing up for this experiment?
"The trial in question is not recruiting patients at this time, as per the clinicaltrials.gov website. This study was posted on 4/11/2014 and most recently updated on 12/27/2021. There are presently 3335 other studies that are actively looking for participants."
Answered by AI
Are there any other scientific studies that focus on Quality-of-Life Assessment?
"There are a total of 1511 studies being conducted to assess quality-of-life. Of these, 390 are in the third stage of clinical trials. The majority of research locations for this assessment are based in Shanghai; however, there are 77704 centres running trials globally."
Answered by AI
In how many different medical facilities is this research project being conducted today?
"Currently, this clinical trial is enrolling patients at 100 sites. If you are considering participating in this trial, know that there are locations in Saginaw, Las Vegas and Bozeman as well as 100 other places. To reduce the amount you would need to travel, it might be best to choose a location near where you live."
Answered by AI
How many people will be chosen to participate in this experiment?
"This trial is no longer recruiting patients. It was originally posted on April 11th, 2014 and last updated December 27th, 2021. There are 1824 other trials for adenocarcinoma and 1511 Quality-of-Life Assessment studies that are still looking for participants."
Answered by AI
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