Trial · NCT06964165
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) | Up to approximately 102 weeks | Intent-to-Treat population included all randomized participants whether or not randomized treatment was administered. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria | At week 24 | Intent-to-Treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for PFS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Overall Survival (OS) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for OS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Time to First Subsequent Treatment (TFST) | Up to approximately 154 weeks | As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for TFST data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events. | ||
| SECONDARY | Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5 | Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks) | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Scores on scale | MEAN |
| SECONDARY | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire | Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks). | Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The 0 participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups. | Scores on scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity | Up to approximately 154 weeks | Safety population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dose Modification Due to TEAEs | Up to approximately 154 weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT06964165/outcomes