Trial · NCT06890338
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (OR) by Independent Central Review (ICR) | Up to Approximately 3 years | OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS). |
| Secondary | Percentage of Participants with Adverse Events (AE) | Up to Approximately 3 years | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Secondary | Percentage of Participants with AEs leading to study drug discontinuation or dose modification | Up to Approximately 3 years | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Secondary | Objective Response (OR) by Investigator | Up to Approximately 3 years | OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS. |
| Secondary | Disease Control by ICR | Up to Approximately 3 years | Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS. |
| Secondary | Disease control by Investigator | Up to Approximately 3 years | Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS. |
| Secondary | Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to Approximately 3 years | The GCIG CA-125 response was defined as at least 50% reduction in CA-125. |
| Secondary | Progression-Free Survival (PFS) by investigator | Up to Approximately 3 years | PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first. |
| Secondary | Percentage of Participants that Underwent Interval debulking surgery (IDS) | Up to Approximately 3 years | Percentage of participants that underwent IDS during the course of the study treatment |
| Secondary | Percentage of participants with complete tumor cytoreduction at IDS | Up to Approximately 3 years | Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery |
| Secondary | Percentage of participants with Incomplete Tumor Cytoreduction at IDS | Up to Approximately 3 years | Defined as macroscopically visible residual tumor (≤ 1 cm or \> 1cm) at the end of surgery. |
| Secondary | Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P) | Up to Approximately 3 years | The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items). |
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
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GET https://conductscience.org/api/trials/v1/NCT06890338/registered