Trial · NCT00410813
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Up to 2 years | RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact. |
| Secondary | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Up to 2 years | Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. |
| Secondary | MUC-1 Antigen Response | at 4, 8, 16, and 24 weeks | MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 \<= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression. |
| Secondary | Circulating Tumor Cells (CTC) Response Rate | Up to 4 weeks | CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (\>= 5 cells/7.5 ml), whose CTC level drops to \< 5. |
| Secondary | Change in Serum Bone Turnover Markers Over Time -- NTx | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks. |
| Secondary | Change in Serum Bone Turnover Markers Over Time -- BAP | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks. |
| Secondary | Change in Serum Bone Turnover Markers Over Time | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks. |
| Secondary | Change in Serum Bone Turnover Markers Over Time -- OC | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks. |
| Secondary | Change in Serum Bone Turnover Markers Over Time -- OPG | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks. |
| Secondary | Change in Serum Bone Turnover Markers Over Time -- TRAP | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks. |
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 2 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Mean Patient-reported Pain | Baseline, 8, 16, and 24 weeks | Patient's rating of "worst pain" experienced between prestudy and week 24. Changes of \>=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning. |
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/NCT00410813/registered