Trial · NCT03947385
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicity (DLT) | 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Determine DLT of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Incidence of Adverse Events | Approx. 8 months | Safety and tolerability of IDE196 either as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Maximum Tolerated Dose (MTD) | 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Determine MTD of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Approx. 6 months | Determine RP2D of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Approx. 6 months | Pharmacokinetics of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Plasma Concentrations of Crizotinib administered in combination with IDE196 | Approx. 6 months | Pharmacokinetics of Crizotinib in combination with IDE196 |
| Primary | Plasma Concentrations of Binimetinib administered in combination with IDE196 | Approx. 6 months | Pharmacokinetics of Binimetinib in combination with IDE196 |
| Primary | Overall Response Rate (ORR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 8 months | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria |
| Primary | Duration of Response (DOR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 8 months | RECIST v1.1 |
| Secondary | Progression Free Survival (PFS) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 18 months | RECIST v1.1 |
| Secondary | Overall Response Rate (ORR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts and by prior treatment status (pretreated or treatment naive) by Investigator response assessment | Approx. 18 months | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria |
| Secondary | Duration of Response (DOR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by prior treatment status (pretreated or treatment naive) by Investigator response assessment | Approx. 18 months | RECIST v1.1 |
| Secondary | Disease Control Rate (DCR) by Investigator | Approx. 18 months | RECIST v1.1 |
| Secondary | Area under the plasma concentration versus time curve (AUC) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Area under the plasma concentration curve from time zero extrapolated to infinity (AUCinf) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Area under the plasma concentration curve from time zero to the last measurable concentration time (AUC0-t) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Area under the plasma concentration curve extrapolating the percentage of total drug exposure (AUC%extra) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Peak Plasma Concentration (Cmax) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Time to maximum plasma concentration (Tmax) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
| Secondary | Elimination half-life of Plasma Concentration levels (T1/2) | Approx. 8 months | PK parameters of bupropion, hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, total dabigatran (dabigtran+glucuronide), and the exposures of PDA (as data permits) |
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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