Trial · NCT04094610
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities (DLTs) (Phase 1) | Within 28 days of the first repotrectinib dose | Define the dose limiting toxicities (DLTs) (Phase 1) |
| Primary | Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1) | Within 28 days of the last patient dosed in escalation | To determine the pediatric RP2D (Phase 1) |
| Primary | Overall Response Rate (ORR) (Phase 2) | Two to three years after first dose of repotrectinib | To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2) |
| Secondary | Overall Response Rate (ORR) (Phase 1) | Approximately three years | To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1) |
| Secondary | Clinical Benefit Rate (CBR) (Phase 1 and Phase 2) | Approximately three years | To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2) |
| Secondary | Time to response (TTR) (Phase 1 and Phase 2) | Approximately three years | To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2) |
| Secondary | Duration of response (DOR) (Phase 1 and Phase 2) | Approximately three years | To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2) |
| Secondary | Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2) | Approximately three years | To determine the IC-ORR of repotrectinib in subjects with measurable brain metastases (TPX-005) (Phase 1 and Phase 2) |
| Secondary | Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2) | Approximately three years | CNS-PFS in subjects with measurable brain metastases (Phase 2) |
| Secondary | Progression-free survival (PFS) (Phase 2) | Approximately three years | To determine the PFS (Phase 2) |
| Secondary | Overall survival (OS) (Phase 2) | Approximately three years | To determine the OS (Phase 2) |
| Secondary | Maximum concentration of repotrectinib in plasma (Cmax) | Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days) | To determine the Cmax |
| Secondary | Area under the concentration versus time curve of repotrectinib in plasma (AUC) | Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days) | To determine the AUC |
| Secondary | Number of participants with laboratory abnormalities | Approximately three years | |
| Secondary | Number of Participants with Adverse events | Approximately three years |
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/NCT04094610/registered