Trial · NCT04005144
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 | Recommended Phase 2 Dose | Up to 12 months | Evaluating the number and frequency of adverse events as determined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version (v)5.0 by investigator's assessment will be used to determine the recommended phase 2 dose for future studies. |
| Primary | Number of Participants with Dose Limiting Toxicities | Up to 28 days | A dose limiting toxicity (DLT) is generally defined as a grade 3 or higher, treatment-related adverse event that is attributable to the study treatment during the first 28 days of therapy (Cycle 1). The dose limiting toxicity will be based on the tolerability observed during cycle 1 of treatment/observation. Adverse events will be assessed by the investigators using NCI-CTCAE v5.0. |
| Primary | Number of Total Treatment-Emergent Adverse Events (AEs) | From treatment initiation through study completion, an average of 1 year | Treatment Emergent AEs will be defined by the NCI CTCAE v5.0 as AEs newly occuring after the patient has begun study treatment. |
| Primary | Number of Treatment-Emergent Adverse Events by Grade | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Grade 3 or Greater Treatment-Emergent Adverse Events by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Serious Treatment-Emergent Adverse Events by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events with an Outcome of Death by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events Resulting in Interruption, Reduction, or Delay of study treatment | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Secondary | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | From treatment initiation through study completion, an average of 1 year | RECIST v1.1 will be used to determine the overall response rate defined as participants with a complete response (CR) or a partial response (PR). Point estimate and 95% exact binomial confidence interval (CI) will be obtained for ORR. |
| Secondary | Median Depth of Response Assessed by RECIST v1.1 | From treatment initiation through study completion, an average of 1 year | Will be defined as maximal reduction in tumor size based on Response Evaluation Criteria in Solid Tumors (RECIST) measurement. Median and inter-quartile range will be used to describe the depth of response (the maximal reduction in tumor size based on RECIST measurement). |
| Secondary | Area Under the Plasma Concentration versus Time Curve (AUC) of Brigatinib | At pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose on days 1 and 15 of cycle 1 | Plasma concentration assessment (pharmacokinetic data) of brigatinib during coadministration with binimetinib will be determined by assay at various timepoints. The assay will be done by Takeda / their designated vendor. |
| Secondary | Median Progression Free Survival (PFS) | Up to 6 months | PFS is measured as the time from start of treatment to time of disease progression at 6 months. Kaplan-Meier method will be used to describe the describe the median PFS with 95% CI. |
| Secondary | Median Overall Survival (OS) | Up to 12 months | Overall Survival is measures as the time from start of treatment to time of death, or lost to follow-up. Kaplan-Meier method will be used to describe the describe the median OS at 12 months with 95% CI. |
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/NCT04005144/registered