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Avutometinib + Defactinib + Letrozole for Ovarian Cancer (CHAMELEON Trial)

Phase 2

Recruiting

Led By Rachel Grisham, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Determination that the patient is not a primary surgical candidate by a gynecologic oncologist surgeon; or has undergone an attempted primary debulking with residual RECIST measurable disease.

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Must not have

Patients with a history of hypersensitivity to any of the active (Avutometinib, defactinib) or inactive (hydroxypropylmethylcellulose, mannitol, magnesium stearate) ingredients of the investigational product.

Female patients who are breastfeeding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if a mix of avutometinib, defactinib, and letrozole is a helpful treatment for individuals with low-grade serous ovarian cancer. The researchers

Who is the study for?

This trial is for individuals with low-grade serous ovarian cancer. Participants should meet specific health criteria set by the researchers, but these details are not provided here.

What is being tested?

The study tests a combination of three drugs: Avutometinib, Defactinib, and Letrozole to see if they're effective in treating low-grade serous ovarian cancer.

What are the potential side effects?

While specific side effects are not listed here, common ones may include fatigue, nausea, skin reactions or hormonal changes due to the nature of the medications being tested.

Eligibility Criteria

Inclusion Criteria

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

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A specialist decided surgery isn't my first treatment option, or surgery didn't remove all my cancer.

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My hepatitis B virus load is undetectable with treatment.

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I have a tumor or lymph node that meets the size requirements for measurement.

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I had hepatitis C but am now cured, or I am on treatment with an undetectable viral load.

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My heart pumps well, with an ejection fraction of 50% or higher.

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My blood counts and liver, kidney functions are within required ranges.

Exclusion Criteria

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

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I am allergic to ingredients in the trial medication.

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I am currently breastfeeding.

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I haven't taken any medications or supplements in the last 14 days that could interfere with the study drugs.

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I have had rhabdomyolysis in the past.

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I have had treatment for low-grade serous ovarian cancer or borderline serous tumors.

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I haven't had major surgery in the last 4 weeks, minor surgery in the last 2 weeks, or palliative radiotherapy in the last week.

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I have eye conditions that could increase my risk for retinal vein occlusion.

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I have a history of serious eye surface conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

objective response rate

Secondary study objectives

Occurrence of adverse events

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Avutometinib, Defactinib, and LetrozoleExperimental Treatment3 Interventions

Enrolled patients will be treated with avutometinib 3.2 mg PO, twice weekly (e.g. M/Th,Tu/F, or W/Sa) + defactinib 200 mg PO BID for 3 weeks, followed by a 1 week rest period, in each 4-week (28 day) cycle. Patients will also be treated with letrozole 2.5 mg PO daily, and pre/perimenopausal patients will also receive leuprolide acetate 3.75 mg subcutaneously every 4 weeks or 11.25 mg every 3 months for ovarian suppression while an ovary remains in situ.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defactinib

2013

Completed Phase 1

~60

Letrozole

2002

Completed Phase 4

~3150