Trial · NCT04729608
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC | 4 months | PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first. |
| Secondary | Overall survival | 20 months | Time following the treatment until death |
| Other | Duration of response (DOR) | 9 months | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
| Other | Objective response rate (ORR) | 3 months | Proportion of subjects who have a confirmed partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria |
| Other | Incidence of Treatment Emergent Adverse Events (TEAEs) | 10 months | |
| Other | Quality of Life (QOL) | 10 months | Subject QOL will be assessed using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items). |
| Other | Clinical benefit rate (CBR) | 4 months | |
| Other | Area under the batiraxcept concentration-time curve. | 10 months | |
| Other | Maximum observed batiraxcept concentration. | 10 months | |
| Other | Minimum observed batiraxcept concentration. | 10 months | |
| Other | Pharmacodynamic marker assessment | 10 months | Change from the baseline in GAS6 serum levels. |
| Other | Anti-drug antibody (ADA) titers | 10 months | |
| Other | Cancer antigen 125 (CA-125) levels | 10 months |
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/NCT04729608/registered