Opevesostat
DrugTablet for oral administration.
Other names: MK-5684
NCT Number: NCT06979596
Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.
Researchers will compare MK-5684 to the standard treatments for each cancer type in this study.
The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Hospital Aleman ( Site 0301), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
Tablet for oral administration.
Other names: MK-5684
Tablet for oral administration.
Tablet for oral administration.
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Administered via intramuscular injection.
Tablet for oral administration.
Tablet for oral administration.
Tablet for oral administration.
Tablet for oral administration.
Time frame: Up to approximately 2 years
For all cohorts, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 2 years
For all cohorts, OS is defined the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
For cohort A (participants with breast cancer), CBR is defined as the percentage of participants who have complete response (CR): disappearance of all target lesions; partial response (PR): At least a 30% decrease in the sum of diameters of target lesions; or stable disease (SD): Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), with reference to the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 2 years
For all cohorts, ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 2 years
For all cohorts, for participants who demonstrate CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 8 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 11 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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