Trial · NCT03107988
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MTD/RP2D Determination A1 | All toxicities from enrollment until completion of course 2 (Day 56) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | MTD/RP2D Determination A2 | All toxicities from enrollment until completion of course 2 (Day 56) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | MTD/RP2D Determination B2 | All toxicities from enrollment until completion of course 1 (Day 28) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Non-Hematological Toxicities (A1 and B1) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (A1 and B1) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Non-Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Non-Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics A1 and B1-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable. | hours*ng/mL | MEDIAN |
| SECONDARY | Pharmacokinetics A2-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | hours*ng/mL | MEDIAN | |
| SECONDARY | Pharmacokinetics B2-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | No AUCtau is included for patients in Cohort B2 DL4B or Cohort B2 DL3A as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable. | hours*ng/mL | MEDIAN |
| SECONDARY | Overall Response A1 and B1 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response A2 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response B2 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics A1 and B1-Cmax | Day 15 | ng/mL | MEDIAN | |
| SECONDARY | Pharmacokinetics A2-Cmax | Day 15 | ng/mL | MEDIAN | |
| SECONDARY | Pharmacokinetics B2-Cmax | Day 15 | ng/mL | MEDIAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03107988/outcomes