Trial · NCT01843062
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
NCT01843062, Phase 3, Terminated, AstraZeneca; results first posted 2019-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer. Trials, record NCT01843062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01843062
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
- NCT number
- NCT01843062
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Differentiated Thyroid Cancer
- Interventions
- Selumetinib, Placebo, Radioactive Iodine Therapy
- First posted
- 2013-04-30
- Last updated
- 2019-08-28
- Other registries' IDs
- eudract:2013-000423-14
- Results first posted
- 2019-04-22
- Limitations and caveats
The study was terminated early (based on the findings of the primary analysis at 18 months post-RAI treatment) and all randomised patients who had not yet completed their 3-year follow-up visit were instead to have an end of study phone call.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | At 18 months post-RAI treatment | Patients were defined to be in complete remission if all of the following criteria were demonstrated: 1. Serum thyroglobulin (Tg) levels \<1 nanograms / millilitre (ng/mL) during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis. 2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review. 3. No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review. 4. No histopathological evidence of thyroid cancer on fine needle aspiration (FNA)/biopsy when performed, as assessed by investigator site review. 5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment. |
| Secondary | Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | At 18 months post-RAI treatment | Patients were defined to be in complete remission if all of the following criteria were demonstrated: 1. Serum Tg levels \<1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis. 2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review. 3. No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review. 4. No histopathological evidence of thyroid cancer FNA/biopsy when performed, as assessed by investigator site review. 5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment. |
| Secondary | Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | At 18 months post-RAI treatment | Patients were defined to be in clinical remission if all of the following criteria were demonstrated: 1. Serum Tg levels \<1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis. 2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review. 3. No evidence of thyroid cancer on diagnostic whole body scan (WBS), as assessed by blinded independent central review. 4. No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review. 5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment. |
| Secondary | Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | At 18 months post-RAI treatment | Patients were defined to be in clinical remission if all of the following criteria were demonstrated: 1. Serum Tg levels \<1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis. 2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review. 3. No evidence of thyroid cancer on diagnostic WBS, as assessed by blinded independent central review. 4. No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review. 5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | At 18 months post-RAI treatment | The ITT analysis set included all randomised patients. Patients who were randomised but did not subsequently go on to receive selumetinib/placebo were included in the ITT analysis set. | Percentage of participants | NUMBER |
| SECONDARY | Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | At 18 months post-RAI treatment | The BRAF/NRAS mutation positive analysis set included only those patients from the ITT population whose tumour samples were mutation positive for the oncogenes BRAF or NRAS. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | At 18 months post-RAI treatment | The ITT analysis set included all randomised patients. Patients who were randomised but did not subsequently go on to receive selumetinib/placebo were included in the ITT analysis set. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | At 18 months post-RAI treatment | The BRAF/NRAS mutation positive analysis set included only those patients from the ITT population whose tumour samples were mutation positive for the oncogenes BRAF or NRAS. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | Selumetinib 75 mg BD + RAI | 40.0 | Percentage of participants | ||
| Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | Placebo + RAI | 38.5 | Percentage of participants | ||
| Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | Selumetinib 75 mg BD + RAI | 37.4 | Percentage of participants | ||
| Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | Placebo + RAI | 41.2 | Percentage of participants | ||
| Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | Selumetinib 75 mg BD + RAI | 40.0 | Percentage of participants | ||
| Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set | Placebo + RAI | 38.5 | Percentage of participants | ||
| Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | Selumetinib 75 mg BD + RAI | 37.4 | Percentage of participants | ||
| Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive | Placebo + RAI | 41.2 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selumetinib 75 mg BD + RAI | 155 | |
| Overall Study | STARTED | Placebo + RAI | 78 | |
| Overall Study | Intention to Treat (ITT) Analysis Set | Selumetinib 75 mg BD + RAI | 155 | |
| Overall Study | Intention to Treat (ITT) Analysis Set | Placebo + RAI | 78 | |
| Overall Study | Safety Analysis Set | Selumetinib 75 mg BD + RAI | 154 | |
| Overall Study | Safety Analysis Set | Placebo + RAI | 77 | |
| Overall Study | BRAF/NRAS Mutation Positive Analysis Set | Selumetinib 75 mg BD + RAI | 91 | |
| Overall Study | BRAF/NRAS Mutation Positive Analysis Set | Placebo + RAI | 51 | |
| Overall Study | Ongoing at Primary Analysis Data Cut-off | Selumetinib 75 mg BD + RAI | 134 | |
| Overall Study | Ongoing at Primary Analysis Data Cut-off | Placebo + RAI | 71 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events66
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 | Periorbital oedema | Eye disorders | Selumetinib 75 mg BD + RAI | 8 | 154 | 8 |
| other | Periorbital oedema | Eye disorders | Placebo + RAI | 0 | 77 | 0 |
| other | Constipation | Gastrointestinal disorders | Selumetinib 75 mg BD + RAI | 15 | 154 | 15 |
| other | Constipation | Gastrointestinal disorders | Placebo + RAI | 3 | 77 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Selumetinib 75 mg BD + RAI | 68 | 154 | 78 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + RAI | 12 | 77 | 13 |
| other | Dry mouth | Gastrointestinal disorders | Selumetinib 75 mg BD + RAI | 15 | 154 | 15 |
| other | Dry mouth | Gastrointestinal disorders | Placebo + RAI | 3 | 77 | 3 |
| other | Rash follicular | Skin and subcutaneous tissue disorders | Selumetinib 75 mg BD + RAI | 13 | 154 | 13 |
| other | Rash follicular | Skin and subcutaneous tissue disorders | Placebo + RAI | 0 | 77 | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selumetinib 75 mg BD + RAI | 1 | 155 |
| Total, all-cause mortality | Placebo + RAI | 2 | 78 |
| Total, other adverse events | Selumetinib 75 mg BD + RAI | 141 | 154 |
| Total, other adverse events | Placebo + RAI | 43 | 77 |
| Total, serious adverse events | Selumetinib 75 mg BD + RAI | 7 | 154 |
| Total, serious adverse events | Placebo + RAI | 0 | 77 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35192411 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selumetinib 75 mg BD + RAI vs Placebo + RAI: deaths from any cause | Trial comparisons |
| Selumetinib 75 mg BD + RAI vs Placebo + RAI: 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/NCT01843062
GET https://conductscience.org/api/trials/v1/NCT01843062/events?page=2