Trial · NCT05725200
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pre-Screening: Obtain a combined pharmacogenomic profile which can be used to provide a MTB-nominated treatment | In average of 3 months | Number of participants that obtain a full combined pharmacogenomic profile which can be used to provide an MTB-nominated treatment in the Main Study. |
| Primary | Main Study: To evaluate the anti-tumor activity, measured as objective response rate (ORR) of MTB-nominated therapies with drugs not approved or implemented in standard of care (SOC) for treatment of mCRC. | Through study completion, in average 6 months | Number of patients who achieve objective response according RECIST 1.1 in the total study population and each study drug cohort of MTB-nominated therapies with drugs not approved or implemented SOC for treatment of mCRC. |
| Secondary | Pre-Screening: To obtain a full combined pharmacogenomic profile from a tumor biopsy that is eligible for treatment decisions in a standard oncology practice. | Through study completion, approximately 4 years | Pre-Screening: Number of participants who achieve a full combined pharmacogenomic profile eligible for treatment decisions either by * An MTB-nominated treatment provided in the Main Study * An MTB-nominated treatment considered as SOC * An MTB-nominated treatment not considered as SOC and not provided in the Main Study * No MTB-nominated treatment suggested |
| Secondary | Main Study: Progression-free survival (PFS) and duration of response (DOR) | Through study completion, approximately 6 months | Progression-free survival (PFS) and duration of response (DOR) by RECIST 1.1, of participants receiving an MTB-nominated anti-cancer therapy, by calculation of number of days, weeks or years. |
| Secondary | Main Study: Overall survival (OS) | Through study completion, approximately 6 months | OS of participants receiving MTB-nominated anti-cancer therapy, defined as the time from first dose of MTB-nominated treatment to date of death from any cause by calculation of number of days, weeks or years. |
| Secondary | Main Study: Safety and tolerability of the different MTB-nominated treatments | Through study completion, approximately 6 months | Register adverse events (AE) in accordance with CTCAE v 5.1 |
| Secondary | Main Study: Objective response of an MTB-nominated anti-cancer therapy compared to objective response to the prior line(s) SOC treatment. | Through study completion, approximately 6 months | Number of patients who achieve objective response according to RECIST 1.1 from anti-cancer therapy (SOC) in prior lines. |
| Secondary | Main Study: Efficacy of MTB-nominated anti-cancer therapy compared to the efficacy of prior lines SOC treatment. | Through study completion, approximately 6 months. | DOR and PFS by RECIST 1.1 of participants receiving an MTB-nominated treatment and from anti-cancer therapy received in prior lines of SOC in each patient, by calculation of number of days, weeks or years. |
| Secondary | Main study: Objective response of an MTB-nominated anti-cancer therapy compared to objective response to the next line(s) SOC treatment. | Through study completion, approximately 6 months. | Number of patients who achieve objective response according to RECIST 1.1 from receiving anti-cancer therapy in the next/later lines. |
| Secondary | Main study: Efficacy of an MTB-nominated anti-cancer therapy compared to the efficacy achieved by the next line(s) of SOC treatment. | Through study completion, approximately 6 months. | DOR and PFS by RECIST 1.1 of participants receiving an MTB-nominated treatment and from anti-cancer therapy in the next/later lines of SOC treatment in each patient, by calculation of number of days, weeks or years. |
| Secondary | Main study: Patient-reported outcome measures. | Through study completion, approximately 6 months. | Describe patient-reported quality of life during the MTB-nominated treatment, registered by EORTC Quality of Life Questionnaire (QLQ)-C30 questionnaire. The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. |
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.
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