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Trial · NCT00410813

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression-free SurvivalUp to 2 yearsAll eligible patients were included in this analysis.weeksMEDIAN
SECONDARYResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Up to 2 yearsAll eligible patientsparticipantsNUMBER
SECONDARYMUC-1 Antigen Responseat 4, 8, 16, and 24 weeksMUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.
SECONDARYCirculating Tumor Cells (CTC) Response RateUp to 4 weeks
Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.
participantsNUMBER
SECONDARYChange in Serum Bone Turnover Markers Over Time -- NTxat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.nM BCEMEAN
SECONDARYChange in Serum Bone Turnover Markers Over Time -- BAPat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.ug/LMEAN
SECONDARYChange in Serum Bone Turnover Markers Over Timeat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.pg/mLMEAN
SECONDARYChange in Serum Bone Turnover Markers Over Time -- OCat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.ng/mLMEAN
SECONDARYChange in Serum Bone Turnover Markers Over Time -- OPGat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.pmol/LMEAN
SECONDARYChange in Serum Bone Turnover Markers Over Time -- TRAPat baseline, 4, and 8 weeksNumber of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.U/LMEAN
SECONDARYNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugUp to 2 years
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
ParticipantsNUMBER
SECONDARYMean Patient-reported PainBaseline, 8, 16, and 24 weeksAll patients with non-missing values were analyzedunits on a scaleMEAN

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.

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