Trial · NCT01306942
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | mg | NUMBER | |
| PRIMARY | Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I). | Up to cycle 1 | mg | NUMBER | |
| PRIMARY | Objective Response Rate (ORR) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants Who Experienced Adverse Events (AE) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Evaluate the Clinical Benefit Rate (CBR) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progression (TTP) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Response Duration (RD) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Cycle 1 day 2 and day 18 | Two participant samples for cycle 1 day 18 could not be obtained. | ng/mL | MEAN |
| SECONDARY | Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I) | Cycle 1 day 2 and day 18 | Two participant samples for cycle 1 day 18 could not be obtained. | ng·h/mL | MEAN |
| SECONDARY | Phosphorylated SRC (p-SRC) Protein Expression Change in Peripheral Blood Mononuclear Cells After 8 Hours of Treatment (Phase II) | Cycle 1 day 1 at 0 hours and at 8 hours | Absorbance 450 nm | MEAN | |
| SECONDARY | Phosphorylated AKT (p-AKT) Protein Expression Change in Peripheral Blood Mononuclear Cells After 8 Hours of Treatment (Phase II) | Cycle 1 day 1 at 0 hours and at 8 hours | Absorbance 450 nm | MEAN | |
| SECONDARY | Phosphorylation Status of Phosphorylated SRC (p-SRC) in Skin After Treatment (Phase I) | Cycle 1 day 1 at 0 hours and at 8 hours, cycle 1 day 4 and cycle 2 day 1 | Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 and cycle 2 day 1. | score on a scale | MEAN |
| SECONDARY | Phosphorylation Status of Phosphorylated SRC (p-SRC) in Skin After Treatment (Phase II) | Cycle 1 day 1 at 0 hours and at 8 hours | Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours. | score on a scale | MEAN |
| SECONDARY | Phosphorylation Status of Phosphorylated AKT (p-AKT) in Skin After Treatment (Phase I) | Cycle 1 day 1 at 0 hours and at 8 hours and cycle 2 day 1 | Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours and cycle 2 day 1. | score on a scale | MEAN |
| SECONDARY | Phosphorylation Status of Phosphorylated AKT (p-AKT) in Skin After Treatment (Phase II) | Cycle 1 day 1 at 0 hours and at 8 hours | Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours. | score on a scale | MEAN |
| SECONDARY | Phosphorylation Status of Phosphorylated ERK (p-ERK) in Skin After Treatment (Phase I) | Cycle 1 day 1 at 0 hours and at 8 hours, cycle 1 day 4 at 8 hours and cycle 2 day 1 at 8 hours | Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 at 8 hours and cycle 2 day 1 at 8 hours. | score on a scale | MEAN |
| SECONDARY | Phosphorylation Status of Phosphorylated ERK (p-ERK) in Skin After Treatment (Phase II) | Cycle 1 day 1 at 0 hours and at 8 hours | Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Correlation Between Lymphocytosis and Efficacy. | Cycle 1 | Participants | COUNT_OF_PARTICIPANTS |
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/outcomes