In short
Clinical trials investigating MEGESTROL ACETATE are studying its use in people with certain cancers, including breast, ovarian, endometrial, and adrenocortical carcinoma. These trials are looking at treatment benefit, such as tumor response and progression-free survival, in specific patient groups and study phases.
Key points
- Clinical trials investigating MEGESTROL ACETATE are focused on cancer treatment research. One Phase 4 study includes people with selected solid tumors such as breast, ovarian, and endometrial cancer and measures progression-free survival. Another Phase 2 study in advanced adrenocortical carcinoma tests a treatment strategy and measures objective response rate. Both studies are authorised and involve patient groups with specific cancer types. The trial data shows MEGESTROL ACETATE being studied in combination or comparison settings rather than as a stand-alone topic. These trials are designed to learn whether the treatment approach helps control cancer better.
Clinical trials overview
The available trial data shows MEGESTROL ACETATE being studied in cancer research, not as a general medicine overview. The trials focus on people with selected solid tumors and advanced adrenocortical carcinoma.
Both studies are interventional trials, which means researchers are testing treatments and measuring the results in patients.
Study in selected solid tumors
One authorised Phase 4 trial, called MK-5684-015, studies people with breast cancer, ovarian cancer, and endometrial cancer.
This study includes 294 participants and compares MK-5684 with standard of care, which means the usual treatment used in practice.
MEGESTROL is listed among the study drugs in this trial, together with other treatments such as medroxyprogesterone, exemestane, letrozole, tamoxifen, fulvestrant, hydrocortisone, dexamethasone, fludrocortisone, and opevesostat.
The main goal is to compare the treatments using progression-free survival (PFS), which means the time patients live without the cancer getting worse.
The trial uses RECIST 1.1, a standard way to measure tumor change on scans, and the results are checked by blinded independent central review (BICR), which is a review by experts who do not know which treatment the patient received.
Study in adrenocortical carcinoma
The second trial is a Phase 2 study in advanced adrenocortical carcinoma, also called the PESETA trial.
It is authorised and plans to enroll 80 patients with advanced or metastatic disease, meaning the cancer has spread or is not limited to one area.
This study tests whether adding progesterone to standard chemotherapy improves results compared with placebo, which is an inactive look-alike treatment.
MEGESTROL appears in the trial data as “MEGACE 160 mg compresse,” while the study also includes doxorubicin, cisplatin, etoposide, and mitotane.
The study compares the two arms using Objective Response Rate (ORR), which is the proportion of patients whose cancer shrinks in a measurable way.
Response is assessed with RECIST criteria, a standard method for checking tumor response on scans.
What the trials measure
The main outcome in the Phase 4 solid tumor trial is progression-free survival across all cohorts.
The main outcome in the Phase 2 adrenocortical carcinoma trial is objective response rate between the two treatment groups.
These outcomes help researchers learn whether the study treatment can delay cancer growth or shrink tumors in the target patient groups.
Who the trials are for
The trial populations are defined by cancer type rather than by a broad general population.
One study is for people with selected solid tumors, especially breast, ovarian, and endometrial cancer.
The other study is for patients with advanced adrenocortical carcinoma, including metastatic disease.
Because the trials are authorised and still research studies, participation depends on meeting the specific eligibility rules for each protocol.
Study design and phases
The first trial is a Phase 4 study, which usually means later-stage research that compares treatments in a more real-world setting.
The second trial is a Phase 2 study, which is designed to look more closely at whether the treatment approach works in a specific cancer group.
Together, these studies show MEGESTROL ACETATE being investigated in different cancer settings, with different goals and endpoints.