Trial · NCT01727336
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months | Safety Analysis Set (SAF) consisted of all patients who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Progression Free Survival (PFS). | Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months | The All Treated Set (ATS) included all randomized patients who received any study drug | Months | MEDIAN |
| SECONDARY | Part 1: Progression Free Survival (PFS). | The time frame for Part 1 of the study was up to 21.6 months | Full Analysis Set; all subjects randomized in Part 1 of the study | Months | MEDIAN |
| SECONDARY | Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months] | Up to 21.6 months | Full Analysis Set; all subjects randomized in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Objective Response Rate (ORR) | Up to 21.6 months from randomization in Part 1 of the study | Full Analysis Set; all subjects randomized in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Disease Control Rate (DCR) | From randomization up to 21.6 months in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Part 1: Duration of Response (DoR) | From randomization up to 21.6 months in Part 1 of the study. | Full Analysis Set; all subjects randomized in Part 1 of the study | months | MEDIAN |
| SECONDARY | Part 2: Progression Free Survival (PFS) for the Subset of Participants With 2 or More Lines of Prior Systemic Chemotherapy | Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months | Subgroup of Part 2 participants:~24 of 63 participants in the dalantercept arm and 22 of 68 participants in the placebo arm had at least 2 lines of prior systemic chemotherapy | Months | MEDIAN |
| SECONDARY | Part 2: Overall Survival. | Patients to be contacted every 3 months for up to 12 months (anticipated) for survival follow-up, as well as tumor assessment scans if progression of disease has not previously been documented. The time frame for Part 2 was up to 29.0 months | The All Treated Set (ATS) included all randomized patients who received any study drug | Months | MEDIAN |
| SECONDARY | Part 2: Objective Response Rate. | Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study | The All Treated Set (ATS) included all randomized patients who received any study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2: Duration of Response | Assessed at 30 days after the last dose of study drug; up to 29.0 months for Part 2 of the study. | The All Treatment Set (ATS) included all randomized patients who received any study drug. Please see Outcome Measure 5 for Objective Response Rate data. Since there were too few participants with events, an estimation of response duration was not able to be calculated due to the early termination of the study. | Months | MEDIAN |
| SECONDARY | Part 2: Disease Control Rate. | Assessed at 30 days after last dose of study drug. The time frame for Part 2 was up to 29.0 months | The All Treated Set (ATS) included all randomized patients who received any study drug | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Part 1: Exploratory PD - Serum BMP9 | From randomization up to 21.6 months in Part 1 of the study | All subjects randomized to Part 1 of the study and treated with at least 1 dose of dalantercept. Given the high degree of variability in serum BMP9 levels in study subjects \[Baseline value 23.55 ng/mL (SD 20.54 ng/mL)\] and the relative small numbers of subjects in each treatment arm, it was decided that the best way to understand a treatment effect was to conduct a pooled analysis of all 29 Part 1 subjects for the comparison of change from Baseline. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Part 2: PD Biomarker Activities. | Assessed at 30 days after the last dose of dalantercept ± 10 days. The time frame for Part 2 was up to 29.0 months. | The All Treated Set (ATS) included all randomized patients who received any study drug, and for whom sufficient blood sample was available to assess the exploratory biomarker. | pg/mL | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01727336/outcomes