Trial · NCT00864253
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines | Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012 | Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected. | months | MEDIAN |
| SECONDARY | Participant Survival | Up to 38 months; Up to data cut off of 30 June 2012 | Intent to treat population | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines | Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months | ITT | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | every 8 weeks; up to data cut off 30 June 2012 | ITT | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response | Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012 | ITT | percent of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Duration of Response (DOR) in Responding Participants | up to data cut off 30 June 2012 | ITT of participants with a confirmed complete or partial overall response | months | MEDIAN |
| SECONDARY | Summary of Treatment-emergent Adverse Events (AEs) | Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012 | Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug | Maximum study drug exposure 106 weeks; data cut off 30 June 2012 | Treated population | participants | NUMBER |
| SECONDARY | Nadir for the Absolute Neutrophil Count (ANC) Measurements | Day 1 up to 106 weeks; up to data cut off 30 June 2012 | Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included | 10^9/L | MEDIAN |
| SECONDARY | Nadir for White Blood Cells (WBCs) Measurements | Day 1 up to 106 weeks; up to data cut off 30 June 2012 | Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included | 10^9/L | MEDIAN |
| SECONDARY | Nadir for Platelet Count Measurements. | Day 1 up to 106 weeks; up to data cut off 30 June 2012 | Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included | 10^9/L | MEDIAN |
| SECONDARY | Nadir for the Hemoglobin Count Measurements | Day 1 up to 106 weeks; up to data cut off 30 June 2012 | Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included. | g/L | MEDIAN |
| SECONDARY | Pharmacokinetic Parameters | On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose | Patients randomized to receive ABI-007 treatment in Australia, Canada, Europe, United Kingdom and United States had the option to participate in sparse PK sampling in this study. Only 44 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed |
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.
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GET https://conductscience.org/api/trials/v1/NCT00864253/outcomes