Table of contents
- Clinical trials overview
- Study in selected solid tumors
- Study in adrenocortical carcinoma
- What the trials measure
- Who the trials are for
- Study design and phases
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.[1][2]
Both studies are interventional trials, which means researchers are testing treatments and measuring the results in patients.[1][2]
Study in selected solid tumors
One authorised Phase 4 trial, called MK-5684-015, studies people with breast cancer, ovarian cancer, and endometrial cancer.[1]
This study includes 294 participants and compares MK-5684 with standard of care, which means the usual treatment used in practice.[1]
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.[1]
The main goal is to compare the treatments using progression-free survival (PFS), which means the time patients live without the cancer getting worse.[1]
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.[1]
Study in adrenocortical carcinoma
The second trial is a Phase 2 study in advanced adrenocortical carcinoma, also called the PESETA trial.[2]
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.[2]
This study tests whether adding progesterone to standard chemotherapy improves results compared with placebo, which is an inactive look-alike treatment.[2]
MEGESTROL appears in the trial data as “MEGACE 160 mg compresse,” while the study also includes doxorubicin, cisplatin, etoposide, and mitotane.[2]
The study compares the two arms using Objective Response Rate (ORR), which is the proportion of patients whose cancer shrinks in a measurable way.[2]
Response is assessed with RECIST criteria, a standard method for checking tumor response on scans.[2]
What the trials measure
The main outcome in the Phase 4 solid tumor trial is progression-free survival across all cohorts.[1]
The main outcome in the Phase 2 adrenocortical carcinoma trial is objective response rate between the two treatment groups.[2]
These outcomes help researchers learn whether the study treatment can delay cancer growth or shrink tumors in the target patient groups.[1][2]
Who the trials are for
The trial populations are defined by cancer type rather than by a broad general population.[1][2]
One study is for people with selected solid tumors, especially breast, ovarian, and endometrial cancer.[1]
The other study is for patients with advanced adrenocortical carcinoma, including metastatic disease.[2]
Because the trials are authorised and still research studies, participation depends on meeting the specific eligibility rules for each protocol.[1][2]
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.[1]
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.[2]
Together, these studies show MEGESTROL ACETATE being investigated in different cancer settings, with different goals and endpoints.[1][2]
