Trial · NCT06508216
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 2_Efficacy of study therapies in each module_objective response rate (ORR) at 6 months. | Within the 6 months of treatment initiation | ORR is defined as the proportion of patients who achieved a confirmed CR or PR within the 6 months of treatment initiation assessed by investigators. |
| Primary | Part 1_Safety and to determine the recommended phase II dose (RP2D) of study therapies in each module | During treatment_to be determined according to modules added later on | measured by the DLTs, frequency and severity of any AEs, TEAEs, SAEs, AESIs graded according to NCI-CTCAE v5.0, proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs; frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0 |
| Secondary | Part 1&2_Progression free survival (PFS) | From the time date of the first dose until progression or death from any cause, whichever occurs first | Defined as the time from the date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, PFS will be censored at the date of last adequate radiological assessment without progression, unless death occurs within ≤ 2 missing assessments following the date of last known progression-free, in which case the death will be counted as a PFS event. |
| Secondary | Part 1&2_Duration of response (DOR) | From cycle 3 (Week 6; each cycle is 28 days) up to 2 years after the EoT, an average of 33 months | Defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause, whichever occurs first. Duration of response will be measured for responding patients (CR or PR) only. |
| Secondary | Part 1&2_Clinical benefit rate (CBR) | During treatment period, a median of 6 months | Defined as the proportion of patients with a complete (CR) or partial response (PR) or with stable disease (SD) \> 6 months. |
| Secondary | Part 1&2_Overall survival (OS) | From the date of the first dose until 24 months after EoT | Defined as the time from the date of first dose until death. Patients alive at last follow-up will be censored at this date. |
| Secondary | Part 2_Frequency of all adverse events | From enrollment to 30 days after EoT for module 1 and for 90 days for module 2 | |
| Secondary | Part 2_Severity of all adverse events | From enrollment to 30 days after Eo for module 1 and for 90 days for module 2 | As defined by the NCI-CTCAE v5.0. |
| Secondary | Part 2_Frequency of laboratory abnormalities | From enrollment until progression, median of 6 months | |
| Secondary | Severity of laboratory abnormalities | From enrollment until progression, median of 6 months | Defined by NCI-CTCAE v5.0 |
| Secondary | Proportion of treatment discontinuation due to any AEs. | Treatment Period, median of 6 months | |
| Secondary | Proportion of treatment interruptions due to any AEs. | Treatment Period, median of 6 months | |
| Secondary | Proportion of dose reductions due to any AEs. | Treatment Period, median of 6 months | |
| Secondary | Part 1_efficacy of study therapies in each module_objective response rate (ORR) | Within the 6 months of treatment initiation | ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) assessed by investigators. The objective response will be radiologically assessed every 6 weeks using RECIST v1.1. |
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/NCT06508216/registered