Trial · NCT06315010
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial Objective Response Rate (IC-ORR) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of IC-ORR at any timepoint defined as the rate of patients with partial response (PR) or complete response (CR) for IC lesions, as determined locally by the investigator as judged by best CNS response according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. |
| Secondary | Clinical Benefit Rate (CBR) for intracranial (IC) lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of CBR, defined as the rate of patients with objective response (CR or PR), or stable disease (SD) for IC lesions for at least 24 weeks, as determined locally by the investigator using RANO-BM. |
| Secondary | Disease Control Rate (DCR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of DCR, defined as the percentage of patients with advanced cancer whose therapeutic intervention has led to a CR, PR, or SD for IC lesions, as determined locally by the investigator using RANO-BM. |
| Secondary | Time to Response (TTR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of TTR, defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR for IC lesions, as determined locally by the investigator using RANO-BM. |
| Secondary | Duration of Response (DoR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, observed for patients who achieved a CR or PR for IC lesions, as determined locally by the investigator using RANO-BM. |
| Secondary | Objective Response Rate for extracranial (EC) and overall lesions (EC-ORR) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of EC-ORR at any timepoint defined as the rate of patients with partial response (PR) or complete response (CR) for EC and overall lesions, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v.1.1) criteria. |
| Secondary | CBR for EC and overall lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of CBR at any timepoint defined as the rate of patients with objective response (CR or PR), or SD for EC and overall lesions, for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1 |
| Secondary | DCR for EC and overall lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of DCR, defined as the percentage of patients with advanced cancer whose therapeutic intervention has led to a CR, PR, or SD for EC and overall lesions, as determined locally by the investigator using RECIST v.1.1 |
| Secondary | TTR for EC and overall lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of TTR, defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR for EC and overall lesions, as determined locally by the investigator using RECIST v.1.1 |
| Secondary | DoR for EC and overall lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the efficacy in terms of DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, observed for patients who achieved a CR or PR for EC and overall lesions, as determined locally by the investigator using RECIST v.1.1. |
| Secondary | Best percentage of change in tumor burden | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To evaluate the best percentage of change in tumor burden determined locally by the investigator using RANO-BM criteria for IC lesions and RECIST v.1.1 for EC and overall lesions. |
| Secondary | Progression-Free Survival (PFS) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, determined locally per RANO-BM criteria for IC lesions and RECIST criteria v.1.1 for EC and overall lesions. |
| Secondary | Overall Survival (OS) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To determine the OS, defined as the period from treatment initiation to death from any cause, determined locally by the investigator. |
| Secondary | Neurologic function | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To assess the patient neurologic function with the Neurologic Assessment in Neuro-Oncology (NANO) scale |
| Secondary | Quality of life (QoL) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To evaluate changes from baseline and during repotrectinib treatment in terms of patient-reported outcome (PRO) assessments of QoL and treatment-related symptoms as measured by EORTC QLQ-C30 scale. EORTC QLQ-C30 scale aims to measure cancer patients' physical, psychological and social functions. Scale and single items are transformed into scores ranging from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology. |
| Secondary | QoL with the brain cancer specific questionnaire (QLQ-C20). | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months. | To evaluate changes during repotrectinib treatment in terms of PRO assessments of QoL and treatment-related symptoms as measured by EORTC QLQ-C20 scale. EORTC QLQ-BN20 brain specific tool aims to measure the effects of brain tumors and its treatment on symptoms, functions and health-related quality of life. Scale and single items are transformed into scores ranging from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology. |
| Secondary | Safety and tolerability | Through study completion, an average of 13 months. | To evaluate the safety and toxicity profile of treatment with of repotrectinib as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Other | Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes | Through study completion, an average of 13 months. | Gene expression profiling analyses performed on blood samples to investigate the potential association with clinical outcomes. |
| Other | Exploratory endpoint: ROS1 gene expression analysis using baseline tissue samples to investigate the potential association with clinical outcomes | Through study completion, an average of 13 months. | ROS1 gene expression analysis performed on baseline tumor tissue samples to investigate the potential association with clinical outcomes. |
| Other | Exploratory endpoint: Analysis of medical imaging to identify potential biomarkers associated with clinical outcomes | Through study completion, an average of 13 months. | Analysis of oncological biomarkers, such as growth rate of tumor derived by tumor growth rate modeling or tumor heterogeneity according to quantitative estimation through radiomics, may be performed on radiological images to investigate the potential association with clinical outcomes. |
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/NCT06315010/registered