Trial · NCT02470091
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Rate (Cohort I) | At 4 months | 1 patient was excluded due to withdrawal. | participants | NUMBER |
| PRIMARY | Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I) | At 4 months | 1 patient was excluded due to withdrawal. | participants | NUMBER |
| PRIMARY | Disease Control Rate (Cohort II) | At 12 months | 2 patients were excluded due to ineligibility | participants | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | The number of patients who contributed samples varied across cycles. | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | The number of patients who contributed samples varied across cycles. | ng/ml | MEDIAN |
| SECONDARY | Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | All eligible participants | pg/ml | MEAN |
| SECONDARY | Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | All eligible participants | nMol BCE/mmol creatinine | MEAN |
| SECONDARY | Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Minimum of 2 years | 56 patients were treated on protocol therapy. Three hundred seventy-three cycles were reported for the analysis of dose limiting toxicity | cycles | NUMBER |
| SECONDARY | Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | Up to 3 years post-treatment | There were not any patients that met criteria for bone site | ||
| SECONDARY | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | At 4 months | There were not any patients that met criteria for bone site | ||
| SECONDARY | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II) | At 12 months | Patients that met criteria for bone site | proportion of patients | NUMBER |
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/NCT02470091/outcomes