Trial · NCT07026279
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 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study | From first dose of study drug to end of study, an expected average of 6 months | TEAEs during study treatment and follow up periods |
| Primary | Part B: identification of optimal dose of narmafotinib | From first dose of study drug to end of study, an expected average of 6 months | The optimal dose will be selected based on a review of safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and any other available relevant data |
| Secondary | narmafotinib levels in plasma | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) | Measurement of maximum concentration (Cmax) of narmafotinib |
| Secondary | narmafotinib levels in plasma | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) | Measurement of time to Cmax (tmax) of narmafotinib |
| Secondary | narmafotinib levels in plasma | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) | Measurement of clearance of narmafotinib |
| Secondary | Overall response rate (ORR) | Imaging every 56 days per participant, with an expected average duration of 6 months | ORR based on RECIST 1.1 |
| Secondary | Overall survival (OS) | Imaging every 56 days per participant, with an expected average duration of 6 months | OS of participants, defined as time from first dose until death from any cause |
| Secondary | Progression free survival (PFS) | Imaging every 56 days per participant, with an expected average duration of 6 months | PFS of participants, defined as time from first dose to date of first observed progression, based on RECIST, or death from any cause (whichever comes first) |
| Secondary | Clinical benefit rate (CBR) | Imaging every 56 days per participant, with an expected average duration of 6 months | CBR defined as the proportion of patients with complete response (CR) + partial response (PR) + stable disease (SD) with SD for at least 6 months |
| Secondary | Duration of response (DOR) | Imaging every 56 days per participant, with an expected average duration of 6 months | DOR based on RECIST defined as the time from the date of the first confirmed response to the date of progression or death |
| Secondary | Disease control rate (DCR) | Imaging every 56 days per participant, with an expected average duration of 6 months | DCR based on RECIST defined as the proportion of participants who achieve complete response (CR), partial response (PR) or stable disease (SD) |
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.
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GET https://conductscience.org/api/trials/v1/NCT07026279/registered