Trial · NCT03366103
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 34
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 1 | DLT | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 2 | DLT | 2 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 1 | No DLT | 6 | Participants | |
| Number of Participants With Dose Limiting Toxicities (Phase I) | Phase 1 - Dose Level 2 | No DLT | 1 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Partial Response (PR) or Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Stable Disease (SD) | 0 | Participants | |
| Overall Response Rate (ORR) (Phase II) | Phase 2 | Progression (PD) | 1 | Participants | |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 1145 | Standard Deviation 289 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 1966 | Standard Deviation 999 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg | Navitoclax average of individual steady-state trough concentration (avg Cmin,ss) | 2283 | ng/ml | |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 1 Concentration 6 hours after dose (C6h) | 1808 | Standard Deviation 980 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 1 Concentration 6 hours after dose (C6h) | 3254 | Standard Deviation 1233 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 Concentration 6 hours after dose (C6h) | 2260 | Standard Deviation 993 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 Concentration 6 hours after dose (C6h) | 2830 | Standard Deviation 1190 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 Concentration 6 hours after dose (C6h) | 3450 | ng/ml | |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 maximum concentration (Cmax) | 2393 | Standard Deviation 913 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 maximum concentration (Cmax) | 3060 | Standard Deviation 1070 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg | Navitoclax Cycle 1 Day 15 maximum concentration (Cmax) | 3910 | ng/ml | |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 150 mg + Vistusertib 35 mg | Vistusertib average of individual steady-state trough concentration (avg Cmin,ss) | 211 | Standard Deviation 207 | ng/ml |
| Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction | Navitoclax 250 mg + Vistusertib 35 mg | Vistusertib average of individual steady-state trough concentration (avg Cmin,ss) | 559 | Standard Deviation 550 | ng/ml |
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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