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Avutometinib, Defactinib, and 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

CHAMELEON Trial 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.Check my eligibility

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.See study design

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.

CHAMELEON Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My hepatitis B virus load is undetectable with treatment.

Select...

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

Select...

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

Select...

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

Select...

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

CHAMELEON Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

objective response rate

Secondary outcome measures

Occurrence of adverse events

CHAMELEON 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

~2770

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,938 Previous Clinical Trials

588,351 Total Patients Enrolled

73 Trials studying Ovarian Cancer

42,973 Patients Enrolled for Ovarian Cancer

Verastem, Inc.Industry Sponsor

39 Previous Clinical Trials

2,598 Total Patients Enrolled

4 Trials studying Ovarian Cancer

441 Patients Enrolled for Ovarian Cancer

Rachel Grisham, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

688 Total Patients Enrolled

2 Trials studying Ovarian Cancer

305 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is presently enrolling participants. The trial was initially listed on April 29, 2024, and last revised on the same date. There are openings for 20 patients at seven distinct locations."

Answered by AI

In how many distinct locations is this investigation currently being conducted?

"Among the 7 participating sites, options include Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) located in Basking Ridge, Memorial Sloan Kettering Cancer Center situated in New york, and Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) based in Commack. Additionally, there are 4 more locations to choose from."

Answered by AI

Are there any potential risks associated with Avutometinib, Defactinib, and Letrozole when used in patient treatment?

"In this Phase 2 trial, our team at Power rates the safety of Avutometinib, Defactinib, and Letrozole as a 2 on a scale from 1 to 3. This indicates that while there is some existing safety data available for these medications, no efficacy data has been documented yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer

2024. "A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06394804.

All > New York City > Philadelphia