Trial · NCT02544633
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Up to 3 months | Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265 | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months. | Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265 | days | MEDIAN |
| SECONDARY | Progression Free Survival | The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months. | Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265 | months | MEDIAN |
| SECONDARY | 1-Year Survival Rate | From date of first study treatment to death due to any cause, assessed up to 12 months | Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265 | percentage | NUMBER |
| SECONDARY | Overall Survival | From date of first study treatment to death due to any cause, assessed up to 24 months. | Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265 | months | MEDIAN |
| SECONDARY | Number of Patients Experiencing Treatment-emergent Adverse Events | Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment. | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blood Plasma Concentration of MGCD265 - AUC0-6 | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Cmax | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule). | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Ctrough | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule). | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6 | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Blood Plasma Concentration of MGCD265 - Tmax | Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. | PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. | hours | MEDIAN |
| SECONDARY | Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations | At baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications | At baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population | At baseline and at time of confirmation of response to treatment | The study was closed early due to sponsor portfolio prioritization and not due to any patient safety issues. Based on limited individual patient data for whom baseline and post-treatment values were available, the statistical analyses as planned could not be performed. Screening and end of treatment detection results provided. | participants | NUMBER |
| SECONDARY | Blood Plasma Concentration of Soluble MET (sMET) Biomarker | Cycle 1 and Cycle 2 | The Pharmacodynamics Evaluable Population Population defined as all patients in the mITT population for whom PD analytical results were available. Overall number of participants analyzed at baseline and post-baseline are different due to samples not being collected post-baseline for some patients. | pg/mL | MEAN |
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/NCT02544633/outcomes