Trial · NCT02361346
Outcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 51
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Days 1, 3, 5, 8, 10 and 12 | Safety Set comprises of all participants who received any amount of MT-3724 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1 and 2 : Days 1, 3 and 12 | Pharmacokinetic Analysis Set (PAS). All subjects from the Safety Set with sufficient serum concentration data to determine the primary PK parameters. Only those participants with data available at specified timepoints were analyzed. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Hours | MEDIAN |
| PRIMARY | Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Half Life (t1/2) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single-arm as data was not collected for each dose level separately. | Hour | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Volume of Distribution (Vz) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Liters | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Clearance (CL) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Liters per hour | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes | Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study) | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | 10^3 cells per microliter | MEAN |
| PRIMARY | Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed | Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study) | Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number of Participants With Clinically Significant Laboratory Parameters | Up to Day 45 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values | Up to Day 26 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number Participants With Clinically Significant Vital Signs | Up to Day 45 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number of Participants With Clinically Significant Physical Findings | Up to Day 26 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Full Analysis Set. The data was not collected due to early study termination | ||
| SECONDARY | Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | Safety Set comprises of all participants who received any amount of MT-3724. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma | Up to Day 45 | Full Analysis Set. The data was not collected due to early study termination. | ||
| SECONDARY | Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Full Analysis Set. The data was not collected due to early study termination | ||
| SECONDARY | Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Full Analysis Set. The data was not collected due to early study termination | ||
| SECONDARY | Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Full Analysis Set. The data was not collected due to early study termination |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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