Trial · NCT04586660
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 | Objective tumor response | Up to 36 months | Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only) | From baseline until end of treatment, up to a maximum of 36 months | |
| Secondary | Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only) | Month 36 | |
| Secondary | Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only) | From time of surgery until end of treatment, up to a maximum of 36 months | |
| Secondary | Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only) | Up to 36 months | |
| Secondary | Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only) | Up to 36 months | |
| Secondary | Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio) | Baseline to Month 36 | |
| Secondary | Change from baseline in severity of pain assessed by Brief Pain Inventory - Short Form (BPI-SF) score | Baseline to Month 36 | Pain severity will be assessed using Brief Pain Inventory - Short Form. The minimum score is 0 (no pain) and the maximum score is 10 (worst pain imaginable). The higher the score means a worse outcome of more pain. |
| Secondary | Number of participants who experience one or more treatment-emergent adverse events (TEAEs) | Baseline to end of safety follow-up, up to approximately 37 months | |
| Secondary | Number of participants who experience adverse events of special interest | Baseline to end of safety follow-up, up to approximately 37 months | Adverse events of special interest include hypocalcemia, hypercalcemia following investigational product discontinuation, atypical femoral fracture, and osteonecrosis of the jaw. |
| Secondary | Serum XGEVA concentration levels | Up to 36 months |
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/NCT04586660/registered