Trial · NCT01723202
Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer
NCT01723202, Phase 2, Completed, Bhavana Konda; results first posted 2025-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer. Trials, record NCT01723202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01723202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer
- NCT number
- NCT01723202
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Bhavana Konda
- Conditions
- Follicular Thyroid Cancer, Insular Thyroid Cancer, Papillary Thyroid Cancer, Recurrent Thyroid Cancer
- Interventions
- dabrafenib, trametinib
- First posted
- 2012-11-07
- Last updated
- 2025-08-24
- Results first posted
- 2025-08-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Objective Response Rate, Defined as the Proportion of Patients Who Have a Minor Response (MR), Partial Response (PR), or Complete Response(CR)Assessed According to RECIST. | up to 24 weeks | The MR+PR+CR response rate will be estimated for each treatment arm. In determining this rate, the number of patients with RECIST-based MR, PR or CR will be divided by the number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true PR+CR response rate will be calculated. |
| Secondary | Progression-free Survival (PFS) | Up to 4 years or from start of treatment to time of progression or death | The MR+PR+CR response rate will be estimated for each treatment arm. In determining this rate, the number of patients with RECIST-based MR, PR or CR will be divided by the number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true PR+CR response rate |
| Secondary | Overall Survival | up to 4 weeks after study treatment | The Kaplan-Meier method will be used to estimate overall survival. We will also evaluate the proportion of patients who are alive at one year. |
| Secondary | Number of Adverse Events Related to Treatment With GSK2118436 (BRAFi) as a Single Agent and Adverse Events Related to Treatment With GSK2118436 (BRAFi) and GSK1120212 (MEKi) in Combination. | Every 2 weeks for the first 8 weeks, and then every 4-8 weeks thereafter up to 4 weeks after completion of study treatment, up to 1 year | Frequency and severity of adverse events in each of the treatment arms will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described. |
| Secondary | Tolerability of the Regimens in Terms of the Number of Patients Who Required Dose Modifications and/or Dose Delays. | Every 2 weeks for the first 8 weeks, and then every 4-8 weeks thereafter up to 4 weeks after completion of study treatment, up to 1 year | Tolerability of the regimen in each of the treatment arms will be collected and summarized using descriptive statistics. We will also capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial. These tolerability measures will be assessed within each of the treatment arms and we will explore differences in these measures between the arms. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Objective Response Rate, Defined as the Proportion of Patients Who Have a Minor Response (MR), Partial Response (PR), or Complete Response(CR)Assessed According to RECIST. | up to 24 weeks | Participants were analyzed for objective response rate prior to the crossover of Arm A patients to Dabrafenib + Trametinib. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 4 years or from start of treatment to time of progression or death | months | MEDIAN | |
| SECONDARY | Overall Survival | up to 4 weeks after study treatment | months | MEDIAN | |
| SECONDARY | Number of Adverse Events Related to Treatment With GSK2118436 (BRAFi) as a Single Agent and Adverse Events Related to Treatment With GSK2118436 (BRAFi) and GSK1120212 (MEKi) in Combination. | Every 2 weeks for the first 8 weeks, and then every 4-8 weeks thereafter up to 4 weeks after completion of study treatment, up to 1 year | number of events | NUMBER | |
| SECONDARY | Tolerability of the Regimens in Terms of the Number of Patients Who Required Dose Modifications and/or Dose Delays. | Every 2 weeks for the first 8 weeks, and then every 4-8 weeks thereafter up to 4 weeks after completion of study treatment, up to 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group401
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Objective Response Rate, Defined as the Proportion of Patients Who Have a Minor Response (MR), Partial Response (PR), or Complete Response(CR)Assessed According to RECIST. | Arm A: Dabrafenib Alone | 42 | 95% Confidence Interval 23 to 63 | percentage of participants | |
| Overall Objective Response Rate, Defined as the Proportion of Patients Who Have a Minor Response (MR), Partial Response (PR), or Complete Response(CR)Assessed According to RECIST. | Arm B: Dabrafenib + Trametinib | 48 | 95% Confidence Interval 29 to 68 | percentage of participants | |
| Progression-free Survival (PFS) | Arm A: Dabrafenib Alone | 10.7 | Full Range 3.8 to 34.7 | months | |
| Progression-free Survival (PFS) | Arm B: Dabrafenib + Trametinib | 15.1 | Full Range 12.3 to 37.3 | months | |
| Progression-free Survival (PFS) | Cross-over to Dabrafenib + Trametinib | 7.5 | Full Range 2.8 to 38.5 | months | |
| Overall Survival | Dabrafenib Alone | 37.9 | Full Range 23.4 to NA | months | |
| Overall Survival | Dabrafenib + Trametinib | 47.5 | Full Range 27.9 to 57.8 | months | |
| Overall Survival | Cross-over to Dabrafenib + Trametinib | 36 | Full Range 23.4 to NA | months | |
| Number of Adverse Events Related to Treatment With GSK2118436 (BRAFi) as a Single Agent and Adverse Events Related to Treatment With GSK2118436 (BRAFi) and GSK1120212 (MEKi) in Combination. | Arm A: Dabrafenib Alone | Anemia | 11 | number of events | |
| Number of Adverse Events Related to Treatment With GSK2118436 (BRAFi) as a Single Agent and Adverse Events Related to Treatment With GSK2118436 (BRAFi) and GSK1120212 (MEKi) in Combination. | Arm B: Dabrafenib + Trametinib | Anemia | 8 | number of events |
1 to 10 of 401Source ClinicalTrials.gov
See all 401 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-crossover | STARTED | Arm A: Dabrafenib Alone | 26 | |
| Pre-crossover | STARTED | Arm B: Dabrafenib + Trametinib | 27 | |
| Pre-crossover | COMPLETED | Arm A: Dabrafenib Alone | 26 | |
| Pre-crossover | COMPLETED | Arm B: Dabrafenib + Trametinib | 27 | |
| Pre-crossover | NOT COMPLETED | Arm A: Dabrafenib Alone | 0 | |
| Pre-crossover | NOT COMPLETED | Arm B: Dabrafenib + Trametinib | 0 | |
| Post-Crossover of Arm A Patients | STARTED | Arm A: Dabrafenib Alone | 26 | |
| Post-Crossover of Arm A Patients | STARTED | Arm B: Dabrafenib + Trametinib | 27 | |
| Post-Crossover of Arm A Patients | Dabrafenib Alone | Arm A: Dabrafenib Alone | 12 | |
| Post-Crossover of Arm A Patients | Dabrafenib Alone | Arm B: Dabrafenib + Trametinib | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events498
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 | Anemia | Blood and lymphatic system disorders | Arm A: Dabrafenib Alone | 17 | 26 | 17 |
| other | Anemia | Blood and lymphatic system disorders | Arm B: Dabrafenib + Trametinib | 16 | 27 | 16 |
| other | Anemia | Blood and lymphatic system disorders | Crossover to Dabrafenib + Trametinib | 4 | 14 | 4 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm A: Dabrafenib Alone | 4 | 26 | 4 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm B: Dabrafenib + Trametinib | 4 | 27 | 4 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Crossover to Dabrafenib + Trametinib | 0 | 14 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Arm A: Dabrafenib Alone | 2 | 26 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Arm B: Dabrafenib + Trametinib | 2 | 27 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Crossover to Dabrafenib + Trametinib | 1 | 14 | 1 |
| other | Palpitations | Cardiac disorders | Arm A: Dabrafenib Alone | 2 | 26 | 2 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Dabrafenib Alone | 9 | 26 |
| Total, all-cause mortality | Arm B: Dabrafenib + Trametinib | 8 | 27 |
| Total, all-cause mortality | Crossover to Dabrafenib + Trametinib | 2 | 14 |
| Total, other adverse events | Arm A: Dabrafenib Alone | 26 | 26 |
| Total, other adverse events | Arm B: Dabrafenib + Trametinib | 27 | 27 |
| Total, other adverse events | Crossover to Dabrafenib + Trametinib | 14 | 14 |
| Total, serious adverse events | Arm A: Dabrafenib Alone | 6 | 26 |
| Total, serious adverse events | Arm B: Dabrafenib + Trametinib | 6 | 27 |
| Total, serious adverse events | Crossover to Dabrafenib + Trametinib | 0 | 14 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01723202
GET https://conductscience.org/api/trials/v1/NCT01723202/results?page=2