Trial · NCT00390325
Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
NCT00390325, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer. Trials, record NCT00390325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00390325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
- NCT number
- NCT00390325
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Hereditary Thyroid Gland Medullary Carcinoma, Locally Advanced Thyroid Gland Medullary Carcinoma, Multiple Endocrine Neoplasia Type 2A, Multiple Endocrine Neoplasia Type 2B, Recurrent Thyroid Gland Medullary Carcinoma, Sporadic Thyroid Gland Medullary Carcinoma, Stage III Thyroid Gland Medullary Carcinoma AJCC v7, Stage IV Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7
- Interventions
- Sorafenib Tosylate
- First posted
- 2006-10-19
- Last updated
- 2024-02-06
- Results first posted
- 2018-12-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer | Up to 4 weeks after last dose of sorafenib tosylate | Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response. |
| Secondary | Number of Patients With Decreased Calcitonin Levels | Up to 4 weeks after last dose of sorafenib tosylate | Identifying the number of patients with decreased calcitonin levels |
| Secondary | Patient With Decreased Carcinoembryonic Antigen (CEA) Levels | Up to 4 weeks after last dose of sorafenib tosylate | Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels |
| Secondary | Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep) | Up to 4 weeks after last dose of sorafenib tosylate | Median decrease in exchange rate Kep in index lesions |
| Secondary | Degree of Ras-MAPK Signaling Inhibition in the Tumor | Up to 4 weeks after last dose of sorafenib tosylate | Identify the number of patients with degree of Ras-MAPK signaling inhibition |
| Secondary | Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor | Up to 4 weeks after last dose of sorafenib tosylate | Correlated with clinical response. |
| Secondary | Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) | Up to 4 weeks after last dose of sorafenib tosylate | Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET). |
| Secondary | Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Up to 4 weeks after last dose of sorafenib tosylate | Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 |
| Secondary | Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor | Baseline | Percent of patients with RET mutations |
| Secondary | Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity | Baseline | Changes will be correlated with toxicity and clinical response to therapy. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer | Up to 4 weeks after last dose of sorafenib tosylate | 1 patient was not evaluable for RECIST evaluation in Arm B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Decreased Calcitonin Levels | Up to 4 weeks after last dose of sorafenib tosylate | 1 patient was not evaluable in Arm B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient With Decreased Carcinoembryonic Antigen (CEA) Levels | Up to 4 weeks after last dose of sorafenib tosylate | 1 patient was not evaluable in Arm B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep) | Up to 4 weeks after last dose of sorafenib tosylate | kep \[exchange rate constant\] | percentage change | MEDIAN |
| SECONDARY | Degree of Ras-MAPK Signaling Inhibition in the Tumor | Up to 4 weeks after last dose of sorafenib tosylate | Due to low tumor cellularity in the samples obtained, such evaluation was not possible | ||
| SECONDARY | Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor | Up to 4 weeks after last dose of sorafenib tosylate | No data available | ||
| SECONDARY | Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) | Up to 4 weeks after last dose of sorafenib tosylate | maximum SUV | MEDIAN | |
| SECONDARY | Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Up to 4 weeks after last dose of sorafenib tosylate | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity | Baseline | Due to low tumor cellularity in the samples obtained, such evaluation was not possible |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer | Arm A (Hereditary MTC) | 1 | Participants | ||
| Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer | Arm B (Sporadic MTC) | 1 | Participants | ||
| Number of Patients With Decreased Calcitonin Levels | Arm A (Hereditary MTC) | 5 | Participants | ||
| Number of Patients With Decreased Calcitonin Levels | Arm B (Sporadic MTC) | 11 | Participants | ||
| Patient With Decreased Carcinoembryonic Antigen (CEA) Levels | Arm A (Hereditary MTC) | 4 | Participants | ||
| Patient With Decreased Carcinoembryonic Antigen (CEA) Levels | Arm B (Sporadic MTC) | 8 | Participants | ||
| Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep) | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 79 | Full Range 25 to 96 | percentage change | |
| Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | Baseline | 3.73 | Full Range 2.84 to 4.63 | maximum SUV |
| Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 8 week follow up | 2.94 | Full Range 2.24 to 3.88 | maximum SUV |
| Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | Diarrhea | 10 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Hereditary MTC) | 5 | |
| Overall Study | STARTED | Arm B (Sporadic MTC) | 16 | |
| Overall Study | COMPLETED | Arm A (Hereditary MTC) | 5 | |
| Overall Study | COMPLETED | Arm B (Sporadic MTC) | 16 | |
| Overall Study | NOT COMPLETED | Arm A (Hereditary MTC) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Sporadic MTC) | 0 |
Source ClinicalTrials.gov
Adverse events49
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 | Weight loss | General disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 10 | 21 | 10 |
| other | Anorexia | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 8 | 21 | 8 |
| other | Fatigue | General disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 7 | 21 | 7 |
| other | Taste Changes | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 4 | 21 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 17 | 21 | 17 |
| other | Oral Cavity Pain | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 13 | 21 | 13 |
| other | Mucositis | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 10 | 21 | 10 |
| other | Flatulence | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 8 | 21 | 8 |
| other | Abdominal pain or cramping | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 6 | 21 | 6 |
| other | Abdominal bloating | Gastrointestinal disorders | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 4 | 21 | 4 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 1 | 21 |
| Total, other adverse events | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 21 | 21 |
| Total, serious adverse events | Arm A (Hereditary MTC) and Arm B (Sporadic MTC) | 5 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016058 | Cancer Center Support Grant | RATHMELL, WENDY KIMRYN | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Hereditary MTC) vs Arm B (Sporadic MTC): Patient With Decreased Carcinoembryonic Antigen (CEA) Levels | Trial comparisons |
Arm A (Hereditary MTC) vs Arm B (Sporadic MTC): Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer | Trial comparisons |
| Arm A (Hereditary MTC) vs Arm B (Sporadic MTC): Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor | Trial comparisons |
| Arm A (Hereditary MTC) vs Arm B (Sporadic MTC): Number of Patients With Decreased Calcitonin Levels | 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/NCT00390325
GET https://conductscience.org/api/trials/v1/NCT00390325/events?page=2