Trial · NCT02389244
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-progression rate | 8 weeks for cohorts A, B and E, 12 weeks for cohort C, 6 months for cohort D | Proportion of patients without disease progression at the defined timepoint after central radiological review (using RECIST 1.1) |
| Secondary | Progression Free Survival | expected average duration of 3 months | from the date of randomization until the date of radiological progression or death whatever the cause (if death occurs before progression) |
| Secondary | Objective response rate | 6 months | complete response (CR) or partial response (PR) according to RECIST 2009, version 1.1, for all cohorts, and CHOI criteria for chordoma |
| Secondary | Disease control rate at 6 months | 6 months | from the date of randomization until the date of death due to any cause |
| Secondary | Overall survival | 2 years | from the date of randomization until the date of death due to any cause |
| Secondary | Duration of response | expected average duration of 6 months | objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression |
| Secondary | Progression-free rate at 3 and 6 months | at 3 and 6 months | the proportion of patients without progression at 3 and 6 months post randomization |
| Secondary | Time to progression | from date of randomization until the date of first observation of progression (up to 6 months) | from date of randomization until the date of first observation of progression |
| Secondary | Growth Modulation Index defined as ratio of time to progressive disease (PD) under regorafenib to time to progression (TTP) under previous treatment | expected average duration of 3 months | ratio of time to PD under regorafenib to TTP under previous treatment |
| Secondary | Toxicity according to NCI-CTCAE V4-0 | expected average duration of 6 months | according to NCI-CTCAE V4-0 (National Cancer Institut Common Terminology Criteria for Adverse Events) |
| Secondary | Pain assessment using Visual analog scale (VAS), DN4 scale (Neuropathic Pain Diagnostic Questionnaire) and NPSI scale (Neuropathic Pain Symptom Inventory) | expected average duration of 6 months | for chordomas cohort only |
| Secondary | PFS | from date of randomization until the date of first observation of progression (up to 6 months) | Progression Free Survival according to Choi criteria for Chordoma |
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/NCT02389244/registered