Trial · NCT00481091
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase 1: Number of Participants With DLTs in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | mg | NUMBER | |
| PRIMARY | Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | mg | NUMBER | |
| PRIMARY | Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | hours | MEAN |
| PRIMARY | Phase 1: Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg/mL | MEAN |
| PRIMARY | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg•hr/mL | MEAN |
| PRIMARY | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24) | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8 | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg•hr/mL | MEAN |
| PRIMARY | Phase 1: Cmax/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | ng/mL/mg | MEAN |
| PRIMARY | Phase 1: AUC8/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | ng•hr/mL/mg | MEAN |
| PRIMARY | Phase 1: AUC24/Dose | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8 | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | ng•hr/mL/mg | MEAN |
| PRIMARY | Phase 1: Terminal Phase Elimination Rate Constant (β) for Navitoclax | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment. | 1/H | MEAN |
| PRIMARY | Phase 1: Terminal Phase Elimination Half-life (t1/2) of Navitoclax | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment. | hours | MEAN |
| PRIMARY | Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs | From first dose of study drug to 30 days post-last dose. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing | Cycle 1 Day 1: 4-8 h postdose; Cycle 1 Day 15: predose; Cycle 3 Day 1: predose, 4-8 h postdose; Cycle 5 Day 1: predose, 4-8 h postdose; Cycle 7 Day 1: predose, 4-8 h postdose; Cycle 9 Day 1: predose, 4-8 h postdose | Participants with an assessment at given time point. It was pre-specified in the statistical analysis plans to analyze the dose-normalized assessments in phase 2 navitoclax arms combined. | (ng/mL)/mg | 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.
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GET https://conductscience.org/api/trials/v1/NCT00481091/outcomes