Trial · NCT02391038
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 51
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks) | |
| Primary | Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | |
| Primary | Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Phase 1: Up to Cycle 1 (3 weeks) | Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count\[ANC\]less than\[\<\]500 cells/millimeter\[mm\]\^3); \>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets \<25,000/mm\^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;\>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;\>=Grade 3 diarrhea despite optimal supportive care measures;any other \>=Grade 3 nonhematologic toxicity except brief(\<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (\>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other\>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. |
| Primary | Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation. |
| Primary | Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute \[bpm\]). |
| Primary | Phase 1- Recommended Phase 2 Dose (RP2D) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which \<=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than\<500 cells mm\^3;\>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets \<25,000/mm\^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;\>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;\>=Grade 3 diarrhea despite optimal supportive care measures;any other \>=Grade 3 nonhematologic toxicity except brief(\<1 week)Grade 3 fatigue;Inability to start next therapy cycle\>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other\>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. |
| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Serum Concentration for TAb | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose |
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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