Trial · NCT00923247
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)
NCT00923247, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT00923247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT00923247
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Medullary Thyroid Carcinoma
- Interventions
- Bortezomib, Vandetanib
- First posted
- 2009-06-18
- Last updated
- 2018-11-29
- Results first posted
- 2017-05-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib | 80 days | 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. |
| Primary | Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib | 80 days | 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. |
| Primary | Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | 4 months | 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. |
| 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 | 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). |
| 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 | 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. |
| Secondary | Progression Free Survival (PFS) | 2-3 years | 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. |
| Secondary | Number of Participants With Adverse Events | Date treatment consent signed to date off study, approximately 7 years and 9 days | 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. |
| Secondary | Number of Participants With Tumor Biomarker Calcitonin (CTN) Response | 4 weeks | 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. |
| Secondary | Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response | 4 weeks | 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. |
| 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 | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib | Phase 1 | 300 | mg | ||
| Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib | Phase 1 | 1.3 | mg/m^2 | ||
| Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | Phase 2 A | Complete Response | 0 | Participants | |
| Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | Phase 2 A | Partial Response | 0 | Participants | |
| Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | Phase 2 A | Stable Disease | 0 | Participants | |
| Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | Phase 2 A | Progressive Disease | 1 | Participants | |
| Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | Phase 2 A - Vandetanib and Bortezomib at the MTD | 3.67 | months | ||
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 | Phase 1 | Complete Response | 0 | Participants | |
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 | Phase 2A | Complete Response | 0 | Participants | |
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 | Phase 1 | Partial Response | 6 | Participants |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 - Vandetanib and Bortezomib | 21 | |
| Overall Study | STARTED | Phase 2 A - Vandetanib and Bortezomib at the MTD | 1 | |
| Overall Study | COMPLETED | Phase 1 - Vandetanib and Bortezomib | 21 | |
| Overall Study | COMPLETED | Phase 2 A - Vandetanib and Bortezomib at the MTD | 1 | |
| Overall Study | NOT COMPLETED | Phase 1 - Vandetanib and Bortezomib | 0 | |
| Overall Study | NOT COMPLETED | Phase 2 A - Vandetanib and Bortezomib at the MTD | 0 |
Source ClinicalTrials.gov
Adverse events262
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Phase 1 | 7 | 21 | 16 |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2 A | 0 | 1 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 | 3 | 21 | 6 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 A | 0 | 1 | 0 |
| other | Alanine aminotransferase increased | Investigations | Phase 1 | 20 | 21 | 72 |
| other | Alanine aminotransferase increased | Investigations | Phase 2 A | 1 | 1 | 1 |
| other | Alkaline phosphatase increased | Investigations | Phase 1 | 4 | 21 | 10 |
| other | Alkaline phosphatase increased | Investigations | Phase 2 A | 0 | 1 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase 1 | 1 | 21 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase 2 A | 0 | 1 | 0 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 | 0 | 21 |
| Total, all-cause mortality | Phase 2 A | 0 | 1 |
| Total, other adverse events | Phase 1 | 21 | 21 |
| Total, other adverse events | Phase 2 A | 1 | 1 |
| Total, serious adverse events | Phase 1 | 4 | 21 |
| Total, serious adverse events | Phase 2 A | 1 | 1 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase 1 vs Phase 2 A: Number of Participants With Adverse Events | Trial comparisons |
| Phase 1 vs Phase 2 A: deaths from any cause | Trial comparisons |
| Phase 1 vs Phase 2 A: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00923247
GET https://conductscience.org/api/trials/v1/NCT00923247/results?page=2