Trial · NCT06936527
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab | up to day 28 | Dose-limiting toxicities were defined as events related to XS-03 that were considered an adverse reaction or suspected adverse reaction during the first cycle of treatment |
| Primary | Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab | up to day 28 | MTD is defined as at most 1 patient out of 6 experiencing DLT |
| Primary | Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm | up to 18 months after first dose of last patient | Defined as the percentage of participants that achieve a best overall response of complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria) |
| Secondary | Phase 1b: Objective Response Rate (ORR) of all treated participants | up to 18 months after first dose of last patient | |
| Secondary | Duration of response (DOR) of all treated participants | up to 18 months after first dose of last patient | Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first. |
| Secondary | Progression-free survival (PFS) of treated participants | up to 18 months after first dose of last patient | as determined based on RECIST version 1.1 criteria |
| Secondary | Overall survival (OS) of treated participants | up to 18 months after first dose of last patient | Time in months from date of first dose for phase 1b and randomization for phase 2 to death due to any cause |
| Secondary | Number of Participants With Adverse Events (AEs) of treated participants | up to 28 days after last dose of study drug | The severity of each AE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE). |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in safety monitoring | up to 28 days after last dose of study drug | |
| Secondary | Number of Participants With dose adjustment | up to 28 days after last dose of study drug | AE associated with dose reduction, interruption and discontinuation |
| Secondary | Time to Reach Maximum Peak Plasma Concentration (Tmax) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Maximum Plasma Concentration(Cmax) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Area under the plasma concentration versus time curve from time zero to the last measurable concentration(AUC0-t) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Elimination Half-life (T1/2) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Systemic Clearance From Plasma Following Extravascular Administration (CL/F) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | The volume of distribution(Vd/F) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Average concentration at steady state(Cavg,ss) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
| Secondary | Minimum observed concentration at steady state(Cmin,ss) | From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length) | Pharmacokinetic parameter |
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/NCT06936527/registered