Trial · NCT03093116
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
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 | Recommended Phase 2 Dose (RP2D) (Phase 1) | Within 28 days of the last patient dosed in escalation | To determine the RP2D (Phase 1) |
| Primary | Overall Response Rate (ORR) Phase 2 | Two to three years after first dose of repotrectinib dose | To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2) |
| Secondary | Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) |
| Secondary | Area under the plasma concentration time curve (AUC) of repotrectinib (TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the area under the plasma concentration time curve (AUC) of repotrectinib |
| Secondary | Area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) |
| Secondary | Maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) |
| Secondary | Area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1) | Up to 24 hours post dose | To determine the area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1) |
| Secondary | Maximum plasma concentration (CMAX) of midazolam(TPX-0005) (Phase 1) | Up to 24 hours post dose | To determine the maximum plasma concentration (CMAX) of midazolam(TPX-0005) (Phase 1) |
| Secondary | Plasma concentration of repotrectinib following administration at RP2D (Phase 2) | Pre dose and 4 hours post dose | To evaluate the plasma concentration of repotrectinib following administration at RP2D (Phase 2) |
| Secondary | Preliminary objective response rate (ORR) (Phase 1) | Approximately three years | To determine the preliminary objective response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1) |
| Secondary | Duration of response (DOR) (Phase 2) | Approximately three years | To determine the DOR of repotrectinib (TPX-0005) (Phase 2) |
| Secondary | Clinical benefit rate (CBR) (Phase 2) | Approximately three years | To determine the CBR of repotrectinib (TPX-0005) (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 | Intracranial objective response rate (Phase 2) | Approximately three years | To determine the intracranial objective response rate (Phase 2) |
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/NCT03093116/registered