Trial · NCT02470091
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate (Cohort I) | At 4 months | Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success. |
| 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 | Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Disease Control Rate (Cohort II) | At 12 months | Disease control interval was calculated as the time from enrolment until detection of new disease as determined by the treating physician. Disease control interval of at least 12 months was considered disease control success. |
| 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 | Sample means of trough concentrations of denosumab will be calculated. |
| 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 | Sample medians of trough concentrations of denosumab will be calculated. |
| 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 | Serum c-telopeptide in pg/ml |
| 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 | Urine n-telopeptide to creatinine ratio expressed as nMol BCE/mmol creatinine |
| 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 | The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Secondary | Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | Up to 3 years post-treatment | Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances. |
| Secondary | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | At 4 months | Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances. |
| Secondary | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II) | At 12 months | Disease control interval was calculated at the time from enrolment until detection of new disease as determined by the treating physician. The proportion of patients who experience disease control of at least 12 months will be estimated by the method of Kaplan and Meier. |
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/registered