Trial · NCT04983407
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 | Incidence of adverse events (AEs) | 12 months | Measured by the number of patients with AEs in Phase 1b portion of the study. |
| Primary | Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study | 12 months | Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study. |
| Primary | Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study | 30 months | Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2. |
| Secondary | Pharmacokinetics: AUC | 30 months | Area under the batiraxcept concentration-time curve. |
| Secondary | Pharmacokinetics: Cmax | 30 months | Maximum observed batiraxcept concentration. |
| Secondary | Pharmacokinetics: Tmax | 30 months | Time of maximum observed batiraxcept concentration. |
| Secondary | Pharmacokinetics: t1/2 | 30 months | Apparent terminal half-life of batiraxcept. |
| Secondary | Pharmacodynamic marker assessment | 30 months | Change from the baseline in GAS6 serum levels. |
| Secondary | Anti-drug antibody (ADA) titers | 30 months | Change from baseline in ADA titer. |
| Secondary | Disease control rate | 30 months | Proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
| Secondary | Duration of response (DOR) | 30 months | Measured from the date of partial or complete response to therapy until the cancer progresses. |
| Secondary | Overall survival | 60 months | Time following the treatment until death. |
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/NCT04983407/registered