Trial · NCT00923247
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib | 80 days | mg | NUMBER | |
| PRIMARY | Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib | 80 days | mg/m^2 | NUMBER | |
| PRIMARY | Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | 4 months | No participants were enrolled in the phase IIB cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | 4 months | No participants were enrolled in the phase IIB cohort. One participant was in cohort 2A, thus standard deviation could not be calculated. | months | MEDIAN |
| SECONDARY | Response Rate (Complete Response (CR) + Partial Response (PR) of Adults With a Diagnosis of MTC Treated With Either of Two Regimens: (1) Daily Oral Vandetanib and Bortezomib or (2) Daily Oral Vandetanib | 2-3 years | A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | 2-3 years | A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | Date treatment consent signed to date off study, approximately 7 years and 9 days | No participants were enrolled in the phase IIB cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Tumor Biomarker Calcitonin (CTN) Response | 4 weeks | No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CTN levels that are \>2 times the upper limit of normal are evaluable for biomarker response. There were 16 participants that met this criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response | 4 weeks | No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CEA levels that are \>2 times the upper limit of normal are evaluable for biomarker response. There were 14 participants that met this criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline | Baseline, and for a period of at least 4 weeks post study drug administration | This outcome measure was not analyzed because no participant had a baseline diarrhea that met the criteria for analysis. They needed to have diarrhea 5 times a day for several days in a row and no one had the baseline problem. | ||
| SECONDARY | Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline | Baseline, and for a period of at least 4 weeks post study drug administration | This outcome measure was not analyzed because the number of patients eligible for this response is 0, in both the Phase I and Phase II cohorts. None of the participants met the criteria of \>=5 watery stools per day at baseline. No participants were enrolled in the phase IIB cohort. | ||
| SECONDARY | Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D) | Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose, 1, 2,4, 6, 8, 10 and 24 hours post dose | 7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter. | ng/mL/mg | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D) | Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose | PK samples were only done during the phase I portion of the study. 7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter. Please see other outcome measure modules for details. | hr*ng/mL/mg | GEOMETRIC_MEAN |
| SECONDARY | Terminal Half-Life (T1/2) of Bortezomib | Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose | 7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter. | hour | GEOMETRIC_MEAN |
| SECONDARY | Total Systemic Clearance (CL) of Bortezomib | Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose | 7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Bortezomib Volume of Distribution (Vss) | Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose | 7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter. | Liter | GEOMETRIC_MEAN |
| SECONDARY | Comparison of Steady State Vandetanib Exposure With Relevant Literature Values | Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose | Vandetanib PK samples were only obtained during the phase 1 portion of the study during cycle 3, day 1, where patients received both vandetanib (at steady-state) and bortezomib. 13/14 patients analyzed on day 61 (C3D1). Those patients that were not analyzed had insufficient PK data to calculate this parameter. | ng/mL/mg | MEAN |
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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