Trial · NCT06682988
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
| Primary | Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR) | Up to Approximately 24 months | ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
| Primary | Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Cmax of MIRV |
| Primary | Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine | Up to Approximately 24 months | AUC of MIRV |
| Primary | Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Ctrough of MIRV |
| Primary | Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Vss) of MIRV |
| Primary | Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Tmax of MIRV |
| Primary | Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine | Up to Approximately 24 months | t1/2 of MIRV |
| Secondary | Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
| Secondary | Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to Approximately 24 months | Defined as the time from initial investigator-assessed response (complete response (CR) or partial response (PR)) until progressive disease (PD) as assessed by the investigator or death, whichever occurs first. |
| Secondary | Randomized Phase 2 Cohort: Progression-Free Survival (PFS) | Up to Approximately 24 months | PFS is defined as the time from date of randomization until disease progression or death whichever occurs first. |
| Secondary | Randomized Phase 2 Cohort: Overall Survival (OS) | Up to Approximately 24 months | Overall survival is defined as the time from the date of first dose until the date of death from any cause. |
| Secondary | Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to Approximately 24 months | The GCIG CA-125 response is defined as at least 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days. |
| Secondary | Randomized Phase 2 Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Cmax of MIRV |
| Secondary | Randomized Phase 2 Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine | Up to Approximately 24 months | (AUC) of MIRV |
| Secondary | Randomized Phase 2 Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Ctrough of MIRV |
| Secondary | Randomized Phase 2 Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Vss of MIRV |
| Secondary | Randomized Phase 2 Cohort: Time to Maximal Observed Concentration (Tmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Tmax of MIRV |
| Secondary | Randomized Phase 2 Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine | Up to Approximately 24 months | t1/2 of MIRV |
| Secondary | Both Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06682988/registered