Trial · NCT01747876
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 35
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 280 mg/m2 - Dose Escalation Only | Any primary system organ class total | 1 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 350 mg/m2 - Dose Escalation Only | Any primary system organ class total | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 470 mg/m2 - Dose Escalation Only | Any primary system organ class total | 2 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 280 mg/m2 - Dose Escalation Only | Blood & lymphatic sys. disorders(Thrombocytopenia) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 350 mg/m2 - Dose Escalation Only | Blood & lymphatic sys. disorders(Thrombocytopenia) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 470 mg/m2 - Dose Escalation Only | Blood & lymphatic sys. disorders(Thrombocytopenia) | 1 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 280 mg/m2 - Dose Escalation Only | Gen. disorders & admin. site conditions (fatigue) | 1 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 350 mg/m2 - Dose Escalation Only | Gen. disorders & admin. site conditions (fatigue) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 470 mg/m2 - Dose Escalation Only | Gen. disorders & admin. site conditions (fatigue) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 280 mg/m2 - Dose Escalation Only | Investigations (Platelet count decreased) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 350 mg/m2 - Dose Escalation Only | Investigations (Platelet count decreased) | 0 | Participants | |
| Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment | LEE011 470 mg/m2 - Dose Escalation Only | Investigations (Platelet count decreased) | 1 | Participants | |
| Overall Response Rate | LEE011 280 mg/m2 - Dose Escalation Only | NA | 95% Confidence Interval NA to NA | months | |
| Overall Response Rate | LEE011 350 mg/m2 - Dose Escalation Only | NA | 95% Confidence Interval NA to NA | months | |
| Overall Response Rate | LEE011 470 mg/m2 - Dose Escalation Only | NA | 95% Confidence Interval NA to NA | months | |
| Time to Disease Progression (TTP) Per RECIST 1.1 | MRT Group | 1.8 | 95% Confidence Interval 1.7 to 2.0 | months | |
| Time to Disease Progression (TTP) Per RECIST 1.1 | Neuroblastoma (NB) | 1.8 | 95% Confidence Interval 1.7 to 4.4 | months | |
| Pharmacokinetics (PK) Parameter: AUC0-24 | LEE011 280 mg/m2 - Dose Escalation Only | C1D1 | 9250 | Full Range 4580 to 22000 | h*ng/ml |
| Pharmacokinetics (PK) Parameter: AUC0-24 | LEE011 350 mg/m2 - Dose Escalation Only | C1D1 | 10000 | Full Range 5320 to 43600 | h*ng/ml |
| Pharmacokinetics (PK) Parameter: AUC0-24 | LEE011 470 mg/m2 - Dose Escalation Only | C1D1 | 17600 | Full Range 8010 to 28500 | h*ng/ml |
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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