Trial · NCT04492033
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) | From Day 1 until disease progression or Day 28, whichever came first | Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects |
| Primary | P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC | Up to approximately 24 months | The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review |
| Secondary | Adverse Events (AEs) | Up to approximately 24 months | Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Secondary | Pharmacokinetics (PK) of CTX-009 (ABL001) | Up to approximately 24 months | Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001) |
| Secondary | Objective response rate (ORR) | Up to approximately 24 months | Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review |
| Secondary | Disease control rate (DCR) | Up to approximately 24 months | Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) |
| Secondary | Time to treatment failure (TTF) | Up to approximately 24 months | Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first |
| Secondary | Duration of response (DOR) | Up to approximately 24 months | Time interval from first occurrence of a documented objective response to the time of disease progression |
| Secondary | Progression-free survival (PFS) | Up to approximately 24 months | The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death |
| Secondary | P2: Survival rate | 6 months and 12 months | The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment |
| Secondary | P2: Overall survival (OS) | Up to approximately 24 months | Time from the initiation of treatment to 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/NCT04492033/registered