Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 116 for:    medullary carcinoma

A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00923247
Recruitment Status : Terminated (Terminated due to slow accrual,primary endpoint reached & investigator left NIH.)
First Posted : June 18, 2009
Results First Posted : May 17, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ravi A. Madan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Medullary Thyroid Carcinoma
Interventions Drug: Bortezomib
Drug: Vandetanib
Enrollment 22
Recruitment Details  
Pre-assignment Details No participants were enrolled in the phase IIB cohort.
Arm/Group Title Phase 1 - Vandetanib and Bortezomib Phase 2 A - Vandetanib and Bortezomib at the MTD
Hide Arm/Group Description

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Period Title: Overall Study
Started 21 1
Completed 21 1
Not Completed 0 0
Arm/Group Title Phase 1 Phase 2 A Total
Hide Arm/Group Description

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Total of all reporting groups
Overall Number of Baseline Participants 21 1 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 1 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  76.2%
1
 100.0%
17
  77.3%
>=65 years
5
  23.8%
0
   0.0%
5
  22.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 1 participants 22 participants
56.07  (10) 39.8  (0) 55.34  (10.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 1 participants 22 participants
Female
8
  38.1%
0
   0.0%
8
  36.4%
Male
13
  61.9%
1
 100.0%
14
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 1 participants 22 participants
Hispanic or Latino
1
   4.8%
0
   0.0%
1
   4.5%
Not Hispanic or Latino
20
  95.2%
1
 100.0%
21
  95.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 1 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.8%
0
   0.0%
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.5%
1
 100.0%
3
  13.6%
White
18
  85.7%
0
   0.0%
18
  81.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 1 participants 22 participants
21
 100.0%
1
 100.0%
22
 100.0%
1.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib
Hide Description A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
Time Frame 80 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1
Hide Arm/Group Description:

Patients will be treated with vandetanib to find the maximally tolerated dose.

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: mg
300
2.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib
Hide Description A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
Time Frame 80 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1
Hide Arm/Group Description:

Patients will be treated with bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: mg/m^2
1.3
3.Primary Outcome
Title Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib
Hide Description Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the phase IIB cohort.
Arm/Group Title Phase 2 A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
Stable Disease
0
   0.0%
Progressive Disease
1
 100.0%
4.Primary Outcome
Title Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib
Hide Description Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator).
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the phase IIB cohort. One participant was in cohort 2A, thus standard deviation could not be calculated.
Arm/Group Title Phase 2 A - Vandetanib and Bortezomib at the MTD
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 1
Median (Standard Deviation)
Unit of Measure: months
3.67
5.Secondary Outcome
Title 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
Hide Description Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.
Arm/Group Title Phase 1 Phase 2A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 21 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
Partial Response
6
  28.6%
0
   0.0%
6.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.
Arm/Group Title Phase 1 Phase 2A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 21 1
Median (Full Range)
Unit of Measure: Months
30.2
(1.8 to 93.67)
3.02
7.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.
Time Frame Date treatment consent signed to date off study, approximately 7 years and 9 days
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the phase IIB cohort.
Arm/Group Title Phase 1 Phase 2 A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 21 1
Measure Type: Count of Participants
Unit of Measure: Participants
21
 100.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Tumor Biomarker Calcitonin (CTN) Response
Hide Description Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is <50% increase or decrease in CTN level relative to the baseline level.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 Phase 2A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 16 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
0
   0.0%
Partial response
5
  31.3%
0
   0.0%
Stable disease
6
  37.5%
0
   0.0%
Progressive disease
5
  31.3%
1
 100.0%
No response
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response
Hide Description Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is <50% increase or decrease in CEA level relative to the baseline level.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 - Vandetanib and Bortezomib Phase 2 A
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
0
   0.0%
Partial response
2
  14.3%
0
   0.0%
Stable disease
9
  64.3%
0
   0.0%
Progressive disease
3
  21.4%
1
 100.0%
No response
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline
Hide Description Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
Time Frame Baseline, and for a period of at least 4 weeks post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 - Vandetanib and Bortezomib
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline
Hide Description Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
Time Frame Baseline, and for a period of at least 4 weeks post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 - Vandetanib and Bortezomib
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D)
Hide Description Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
“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.”
Arm/Group Title Phase 1 - Vandetanib and Bortezomib
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
Before Vandetanib Number Analyzed 7 participants
0.98
(0.72 to 1.24)
After Vandetanib Number Analyzed 13 participants
1.92
(0.99 to 2.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1 - Vandetanib and Bortezomib
Comments Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Mann-Whitney
Comments (nonparametric unpaired t-test; assumed homoscedasticity)
13.Secondary Outcome
Title Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D)
Hide Description The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 - Vandetanib and Bortezomib
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*ng/mL/mg
Before Vandetanib Number Analyzed 7 participants
1.27
(0.57 to 1.97)
After Vandetanib Number Analyzed 13 participants
2.39
(1.67 to 3.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1 - Vandetanib and Bortezomib
Comments Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mann-Whitney
Comments (nonparametric unpaired t-test; assumed homoscedasticity)
14.Secondary Outcome
Title Terminal Half-Life (T1/2) of Bortezomib
Hide Description The time it takes for the measured concentration of the drug to drop by half.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
“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.”
Arm/Group Title Phase 1
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: hour
Before Vandetanib Number Analyzed 7 participants
9.4
(3.5 to 15.4)
After Vandetanib Number Analyzed 13 participants
12.5
(7.3 to 17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1
Comments Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.440
Comments [Not Specified]
Method Mann-Whitney
Comments (nonparametric unpaired t-test; assumed homoscedasticity)
15.Secondary Outcome
Title Total Systemic Clearance (CL) of Bortezomib
Hide Description Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
“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.”
Arm/Group Title Phase 1
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: L/hr
Before Vandetanib Number Analyzed 7 participants
78.7
(37.6 to 120)
After Vandetanib Number Analyzed 13 participants
42.9
(30.4 to 55.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1
Comments Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Mann-Whitney
Comments (nonparametric unpaired t-test; assumed homoscedasticity)
16.Secondary Outcome
Title Bortezomib Volume of Distribution (Vss)
Hide Description Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
“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.”
Arm/Group Title Phase 1
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liter
Before Vandetanib Number Analyzed 7 participants
1167
(1049 to 1286)
After Vandetanib Number Analyzed 13 participants
749
(580 to 918)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1
Comments Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mann-Whitney
Comments (nonparametric unpaired t-test; assumed homoscedasticity)
17.Secondary Outcome
Title Comparison of Steady State Vandetanib Exposure With Relevant Literature Values
Hide Description Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."
Time Frame Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.”
Arm/Group Title Phase 1 - Vandetanib and Bortezomib
Hide Arm/Group Description:

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL/mg
Published Literature Number Analyzed 14 participants
4.77  (1.8)
Study 090089 Results Number Analyzed 13 participants
3.96  (0.89)
Time Frame Date treatment consent signed to date off study, approximately 7 years and 9 days.
Adverse Event Reporting Description No participants were enrolled in the phase IIB cohort.
 
Arm/Group Title Phase 1 Phase 2 A
Hide Arm/Group Description

Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study

Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults

All-Cause Mortality
Phase 1 Phase 2 A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 Phase 2 A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/21 (19.05%)      1/1 (100.00%)    
Cardiac disorders     
Electrocardiogram QT corrected interval prolonged  1  0/21 (0.00%)  0 1/1 (100.00%)  1
Endocrine disorders     
Adrenal insufficiency  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Infections and infestations     
Lung infection  1  0/21 (0.00%)  0 1/1 (100.00%)  1
Investigations     
Lymphocyte count decreased  1  1/21 (4.76%)  2 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Vascular disorders     
Hypotension  1  1/21 (4.76%)  1 0/1 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1 Phase 2 A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/21 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  9/21 (42.86%)  31 1/1 (100.00%)  1
Cardiac disorders     
Electrocardiogram QT corrected interval prolonged  1  19/21 (90.48%)  93 1/1 (100.00%)  2
Palpitations  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Sinus bradycardia  1  3/21 (14.29%)  4 0/1 (0.00%)  0
Sinus tachycardia  1  2/21 (9.52%)  3 1/1 (100.00%)  1
Ventricular arrhythmia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Hypothyroidism  1  5/21 (23.81%)  6 0/1 (0.00%)  0
Eye disorders     
Blurred vision  1  3/21 (14.29%)  3 0/1 (0.00%)  0
Dry eye  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Eyelid function disorder  1  3/21 (14.29%)  3 0/1 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  7/21 (33.33%)  16 0/1 (0.00%)  0
Constipation  1  8/21 (38.10%)  12 0/1 (0.00%)  0
Dental caries  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Diarrhea  1  16/21 (76.19%)  78 0/1 (0.00%)  0
Dry mouth  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Dyspepsia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Gastritis  1  1/21 (4.76%)  2 0/1 (0.00%)  0
Gastroesophageal reflux disease  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Mucositis oral  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Nausea  1  13/21 (61.90%)  21 1/1 (100.00%)  1
Oral hemorrhage  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Oral pain  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Vomiting  1  2/21 (9.52%)  2 0/1 (0.00%)  0
General disorders     
Chills  1  5/21 (23.81%)  7 0/1 (0.00%)  0
Edema limbs  1  2/21 (9.52%)  6 0/1 (0.00%)  0
Fatigue  1  13/21 (61.90%)  37 0/1 (0.00%)  0
Fever  1  5/21 (23.81%)  7 0/1 (0.00%)  0
Pain  1  4/21 (19.05%)  7 0/1 (0.00%)  0
Pain in extremity  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Infections and infestations     
Bronchial infection  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Eye infection  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Infections and infestations - Other, specify  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Laryngitis  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Lung infection  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Peripheral nerve infection  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Sinusitis  1  2/21 (9.52%)  3 0/1 (0.00%)  0
Skin infection  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Soft tissue infection  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Urinary tract infection  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  3/21 (14.29%)  6 0/1 (0.00%)  0
Alanine aminotransferase increased  1  20/21 (95.24%)  72 1/1 (100.00%)  1
Alkaline phosphatase increased  1  4/21 (19.05%)  10 0/1 (0.00%)  0
Aspartate aminotransferase increased  1  19/21 (90.48%)  61 1/1 (100.00%)  1
Blood bilirubin increased  1  1/21 (4.76%)  1 0/1 (0.00%)  0
CPK increased  1  5/21 (23.81%)  10 0/1 (0.00%)  0
Creatinine increased  1  7/21 (33.33%)  22 1/1 (100.00%)  2
GGT increased  1  4/21 (19.05%)  4 1/1 (100.00%)  1
Investigations - Other, specify  1  5/21 (23.81%)  9 0/1 (0.00%)  0
Lymphocyte count decreased  1  20/21 (95.24%)  121 1/1 (100.00%)  2
Neutrophil count decreased  1  2/21 (9.52%)  5 0/1 (0.00%)  0
Platelet count decreased  1  17/21 (80.95%)  93 0/1 (0.00%)  0
Weight loss  1  4/21 (19.05%)  6 1/1 (100.00%)  1
White blood cell decreased  1  12/21 (57.14%)  46 0/1 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  5/21 (23.81%)  5 0/1 (0.00%)  0
Hypercalcemia  1  4/21 (19.05%)  5 0/1 (0.00%)  0
Hyperglycemia  1  5/21 (23.81%)  6 0/1 (0.00%)  0
Hyperkalemia  1  8/21 (38.10%)  11 0/1 (0.00%)  0
Hypermagnesemia  1  11/21 (52.38%)  28 0/1 (0.00%)  0
Hypernatremia  1  7/21 (33.33%)  8 0/1 (0.00%)  0
Hyperuricemia  1  1/21 (4.76%)  2 0/1 (0.00%)  0
Hypoalbuminemia  1  19/21 (90.48%)  98 0/1 (0.00%)  0
Hypocalcemia  1  11/21 (52.38%)  22 0/1 (0.00%)  0
Hypoglycemia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Hypokalemia  1  3/21 (14.29%)  17 0/1 (0.00%)  0
Hypomagnesemia  1  6/21 (28.57%)  19 0/1 (0.00%)  0
Hyponatremia  1  10/21 (47.62%)  22 1/1 (100.00%)  2
Hypophosphatemia  1  5/21 (23.81%)  8 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/21 (23.81%)  6 0/1 (0.00%)  0
Back pain  1  5/21 (23.81%)  6 1/1 (100.00%)  1
Bone pain  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Chest wall pain  1  1/21 (4.76%)  4 0/1 (0.00%)  0
Muscle weakness lower limb  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  1/21 (4.76%)  1 1/1 (100.00%)  1
Myalgia  1  6/21 (28.57%)  7 0/1 (0.00%)  0
Neck pain  1  1/21 (4.76%)  2 1/1 (100.00%)  2
Non-cardiac chest pain  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Tumor pain  1  2/21 (9.52%)  4 1/1 (100.00%)  1
Nervous system disorders     
Dizziness  1  4/21 (19.05%)  7 0/1 (0.00%)  0
Dysgeusia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Dysphasia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Headache  1  6/21 (28.57%)  7 0/1 (0.00%)  0
Nervous system disorders - Other, specify  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Neuralgia  1  2/21 (9.52%)  6 0/1 (0.00%)  0
Peripheral sensory neuropathy  1  11/21 (52.38%)  17 0/1 (0.00%)  0
Syncope  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Tremor  1  1/21 (4.76%)  2 0/1 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Depression  1  3/21 (14.29%)  4 0/1 (0.00%)  0
Insomnia  1  6/21 (28.57%)  7 0/1 (0.00%)  0
Renal and urinary disorders     
Hematuria  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Hemoglobinuria  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Proteinuria  1  11/21 (52.38%)  34 1/1 (100.00%)  2
Renal calculi  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Urinary tract obstruction  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Reproductive system and breast disorders     
Testicular pain  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/21 (38.10%)  9 1/1 (100.00%)  1
Dyspnea  1  4/21 (19.05%)  4 0/1 (0.00%)  0
Hoarseness  1  1/21 (4.76%)  4 0/1 (0.00%)  0
Laryngeal inflammation  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Nasal congestion  1  3/21 (14.29%)  3 0/1 (0.00%)  0
Pneumonitis  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Sore throat  1  4/21 (19.05%)  4 1/1 (100.00%)  1
Upper respiratory infection  1  5/21 (23.81%)  5 0/1 (0.00%)  0
Voice alteration  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Dry skin  1  7/21 (33.33%)  9 0/1 (0.00%)  0
Hyperhidrosis  1  5/21 (23.81%)  12 0/1 (0.00%)  0
Nail discoloration  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Nail loss  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  4/21 (19.05%)  6 0/1 (0.00%)  0
Photosensitivity  1  4/21 (19.05%)  5 0/1 (0.00%)  0
Purpura  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Rash acneiform  1  10/21 (47.62%)  20 0/1 (0.00%)  0
Rash maculo-papular  1  9/21 (42.86%)  15 0/1 (0.00%)  0
Skin hyperpigmentation  1  2/21 (9.52%)  2 0/1 (0.00%)  0
Vascular disorders     
Flushing  1  1/21 (4.76%)  3 0/1 (0.00%)  0
Hot flashes  1  2/21 (9.52%)  3 0/1 (0.00%)  0
Hypertension  1  15/21 (71.43%)  24 0/1 (0.00%)  0
Hypotension  1  1/21 (4.76%)  1 0/1 (0.00%)  0
Thromboembolic event  1  1/21 (4.76%)  1 0/1 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ravi Madan
Organization: National Cancer Institute
Phone: 301-480-7168
EMail: madanr@mail.nih.gov
Publications of Results:
Abstract: Phase I/II trial of vandetanib and bortezomib in adults with locally advanced or metastatic medullary thyroid cancer: Phase I results. A. W. Gramza, S. A. Wells, S. Balasubramaniam, and A. T. Fojo Journal of Clinical Oncology 2011 29:15_suppl, 5565-5565
Layout table for additonal information
Responsible Party: Ravi A. Madan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923247     History of Changes
Obsolete Identifiers: NCT00863720
Other Study ID Numbers: 090089
09-C-0089
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: January 23, 2017
Results First Posted: May 17, 2017
Last Update Posted: November 29, 2018