Trial · NCT01306942
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 43
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 1 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 2 | Participants | ||
| Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib + Trastuzumab + Paclitaxel | 100 | mg | ||
| Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I). | Phase I: Dasatinib + Trastuzumab + Paclitaxel | 100 | mg | ||
| Objective Response Rate (ORR) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 23 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 6 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 4 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 29 | Participants | ||
| To Evaluate the Clinical Benefit Rate (CBR) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 24 | Participants | ||
| Time to Progression (TTP) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 23.9 | 95% Confidence Interval 14.9 to NA | months | |
| Progression Free Survival (PFS) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 23.9 | 95% Confidence Interval 10.3 to NA | months | |
| Response Duration (RD) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 18.4 | 95% Confidence Interval 7.4 to NA | months | |
| Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 2 Dasatinib alone | 191.0 | Standard Deviation 92.1 | ng/mL |
| Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 2 Dasatinib alone | 422.3 | Standard Deviation 56.4 | ng/mL |
| Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 18 Dasatinib in combination P and T | 78.4 | Standard Deviation 51.1 | ng/mL |
| Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 18 Dasatinib in combination P and T | 314.4 | Standard Deviation 153.6 | ng/mL |
| Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 2 Dasatinib alone | 530.6 | Standard Deviation 237.1 | ng·h/mL |
| Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 2 Dasatinib alone | 1159.2 | Standard Deviation 128.3 | ng·h/mL |
| Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 18 Dasatinib in combination P and T | 248.1 | Standard Deviation 156.7 | ng·h/mL |
| Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | Day 18 Dasatinib in combination P and T | 1047.3 | Standard Deviation 682.8 | ng·h/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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01306942/results