Trial · NCT02085148
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 | Safety: Maximum Tolerated Dose | approximately after 21 months | MTD is defined as the dose level at which none or 1 of 6 participants experiences dose-limiting toxicity (DLT), when at least 2 of 3-6 participants experience a DLT at the next highest dose |
| Primary | Safety: Recommended Phase II Dose | approximately after 21 months | In order to establish a RP2D, the MTD cohort will be expanded to have at least 12 evaluable subjects to confirm the RP2D. It is expected that at least 15 subjects evaluable for DLTs will be necessary to establish the RP2D of the combination" |
| Primary | Number of participants with Adverse Events | Dose escalation phase:approximately after 21 months; Expansion Phase: approximately after 21 months | Individual listings of adverse events will be provided. The incidence of treatment-emergent adverse events and drug-related adverse events, respectively, will be summarized by worst NCI-CTCAE v 4.0 grade and by dose level |
| Primary | AUC(0-24)md based on nominal dosing | Dose escalation phase:Cycle 1 Day 1, Day 15 and Day 21 | Dose escalation phase has been completed |
| Secondary | Overall survival | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Time to progression | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Tumor response: tumor assessment by RECIST v. 1.1 | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Taste and texture questionnaire of the regorafenib formulations | Dose escalation phase: Cycle 1; Expansion phase:Concomitant: Cycle 1 Day 1;Sequential: Cycle 1 Day 8 | Expansion phase Dose escalation phase |
| Secondary | AUC(0-24)md based on nominal dosing | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
| Secondary | Cmax(0-24)md based on individual dosing | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
| Secondary | Cav(0-24)md based on individual dosing | Expansion phase:Cycle 1 Day1, Day 15 and Day 21; Dose escalation phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase Dose escalation phase |
| Secondary | t1/2eff,md based on individual dosing | Expansion phase:Cycle 1 Day1, Day 15 and Day 21; Dose escalation phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase Dose escalation phase |
| Secondary | AUC(0-24)md based on individual dosing | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
| Secondary | Clearance of irinotecan and SN-38 | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
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/NCT02085148/registered