Trial · NCT03002623
CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer
NCT03002623, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2018-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer. Trials, record NCT03002623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03002623
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer
- NCT number
- NCT03002623
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thyroid Neoplasms, Poorly Differentiated and Undifferentiated Thyroid Cancer, Differentiated Thyroid Cancer
- Interventions
- CUDC-907
- First posted
- 2016-12-26
- Last updated
- 2018-12-21
- Results first posted
- 2018-12-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 6 months | Clinical response, defined as a complete response + partial response (CR+PR) to CUDC-907 treatment, was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. |
| Secondary | Median Amount of Time Subject Survives Without Disease Progression After Treatment | Approximately 6 months | Time in days from initiation of treatment until tumor grows more than 20%. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. |
| Secondary | Median Amount of Time Subject Survives After Therapy | Approximately 12 months | Time in days from the initiation of treatment until death estimated by the Kaplan-Meier method. |
| Secondary | Correlation Between Mutation Status of Tumor and Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | The amount of time subject survives without disease progression is compared by patient tumor mutation status. |
| Secondary | Correlation Between Activation of the Phosphoinositide 3-kinase (PI3K)/Protein Kinase B (AKT) and EGFR/RAS/RAF/MEK/ERK Pathways in Tumor Tissue and Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | The amount of time subject survives without disease progression is compared by the protein levels of PI3K/AKT and epidermal growth factor receptor (EGFR)/rat sarcoma (RAS)/rapidly accelerated fibrosarcoma (RAF)/methyl ethyl ketone (MEK)/extracellular-signal regulated kinase (ERK) in tumor tissue. |
| Secondary | Correlation Between Histone Deacetylase 2 (HDAC2) and Survivin Protein Levels in Tumor Tissue With Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | The amount of time subject survives without disease progression is compared by the protein levels of HDAC2 and surviving in tumor tissue. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. |
| Secondary | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 12 months and 13 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Amount of Time Subject Survives Without Disease Progression After Treatment | Approximately 6 months | One participant was non-evaluable (withdrew consent). | Days | MEDIAN |
| SECONDARY | Median Amount of Time Subject Survives After Therapy | Approximately 12 months | Participants are grouped together because of a small sample size and not enough power to compare the difference between two groups. No statistical analysis to be done. | Days | MEDIAN |
| SECONDARY | Correlation Between Mutation Status of Tumor and Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | This outcome measure was not done. Data was collected but the correlation between mutation status of tumor and progression-free survival was not performed because of only BRAF V600E and the loss of tumor protein 53 (TP53) heterozygosity were found on a single patient each. Since only 1 mutant was found for each, no analysis was done. | ||
| SECONDARY | Correlation Between Activation of the Phosphoinositide 3-kinase (PI3K)/Protein Kinase B (AKT) and EGFR/RAS/RAF/MEK/ERK Pathways in Tumor Tissue and Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | This outcome measure was not done. Data was collected but no samples were analyzed because the experiment was not technically successful due to inconclusive results from immunohistochemistry (study of protein levels in tumor tissue) analysis of P13K/AKT and EGFR/RAS/RAF/MEK/ERK proteins. | ||
| SECONDARY | Correlation Between Histone Deacetylase 2 (HDAC2) and Survivin Protein Levels in Tumor Tissue With Median Amount of Time Subject Survives Without Disease Progression After Treatment | At disease progression | This outcome measure was not done. Data was collected but not analyzed because the assessment of HDAC2 and survivin proteins cannot be reliably performed with consistent results. | ||
| SECONDARY | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 12 months and 13 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Anaplastic Thyroid Cancer | Complete Response | 0 | Participants | |
| Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Poorly Differentiated/Variants of Thyroid Cancer | Complete Response | 0 | Participants | |
| Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Anaplastic Thyroid Cancer | Partial Response | 0 | Participants | |
| Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Poorly Differentiated/Variants of Thyroid Cancer | Partial Response | 0 | Participants | |
| Median Amount of Time Subject Survives Without Disease Progression After Treatment | Anaplastic Thyroid Cancer | 31.3 | Full Range 21 to 45 | Days | |
| Median Amount of Time Subject Survives Without Disease Progression After Treatment | Poorly Differentiated/Variants of Thyroid Cancer | 147 | Full Range 127 to 167 | Days | |
| Median Amount of Time Subject Survives After Therapy | All Participants | 127 | 95% Confidence Interval 66.5 to 187.5 | Days | |
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Anaplastic Thyroid Cancer | 4 | Participants | ||
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Poorly Differentiated/Variants of Thyroid Cancer | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anaplastic Thyroid Cancer | 4 | |
| Overall Study | STARTED | Poorly Differentiated/Variants of Thyroid Cancer | 3 | |
| Overall Study | COMPLETED | Anaplastic Thyroid Cancer | 2 | |
| Overall Study | COMPLETED | Poorly Differentiated/Variants of Thyroid Cancer | 2 | |
| Overall Study | NOT COMPLETED | Anaplastic Thyroid Cancer | 2 | |
| Overall Study | NOT COMPLETED | Poorly Differentiated/Variants of Thyroid Cancer | 1 |
Source ClinicalTrials.gov
Adverse events44
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 | Anaplastic Thyroid Cancer | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Poorly Differentiated/Variants of Thyroid Cancer | 0 | 3 | 0 |
| other | Alkaline phosphatase increased | Investigations | Anaplastic Thyroid Cancer | 1 | 4 | 1 |
| other | Alkaline phosphatase increased | Investigations | Poorly Differentiated/Variants of Thyroid Cancer | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Anaplastic Thyroid Cancer | 0 | 4 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Poorly Differentiated/Variants of Thyroid Cancer | 2 | 3 | 4 |
| other | Constipation | Gastrointestinal disorders | Anaplastic Thyroid Cancer | 1 | 4 | 1 |
| other | Constipation | Gastrointestinal disorders | Poorly Differentiated/Variants of Thyroid Cancer | 0 | 3 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Anaplastic Thyroid Cancer | 1 | 4 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Poorly Differentiated/Variants of Thyroid Cancer | 2 | 3 | 3 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anaplastic Thyroid Cancer | 2 | 4 |
| Total, all-cause mortality | Poorly Differentiated/Variants of Thyroid Cancer | 1 | 3 |
| Total, other adverse events | Anaplastic Thyroid Cancer | 4 | 4 |
| Total, other adverse events | Poorly Differentiated/Variants of Thyroid Cancer | 3 | 3 |
| Total, serious adverse events | Anaplastic Thyroid Cancer | 2 | 4 |
| Total, serious adverse events | Poorly Differentiated/Variants of Thyroid Cancer | 1 | 3 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Anaplastic Thyroid Cancer vs Poorly Differentiated/Variants of Thyroid Cancer: deaths from any cause | Trial comparisons |
Anaplastic Thyroid Cancer vs Poorly Differentiated/Variants of Thyroid Cancer: Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Trial comparisons |
| Anaplastic Thyroid Cancer vs Poorly Differentiated/Variants of Thyroid Cancer: 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/NCT03002623
GET https://conductscience.org/api/trials/v1/NCT03002623/events?page=2