Trial · NCT01286753
A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
NCT01286753, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation. Trials, record NCT01286753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01286753
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
- NCT number
- NCT01286753
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Neoplasms
- Interventions
- Vemurafenib
- First posted
- 2011-01-31
- Last updated
- 2016-09-07
- Results first posted
- 2016-09-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate in TKI-Naive Participants | Up to approximately 4 years | Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \< 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. |
| Secondary | Best Overall Response Rate in TKI-Experienced Participants | Up to approximately 4 years | Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \< 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. |
| Secondary | Clinical Benefit Rate | Up to approximately 4 years | Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \< 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters. |
| Secondary | Duration of Response | From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years) | Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \< 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. |
| Secondary | Progression-Free Survival | From the day of first treatment until the first documented PD or death (up to approximately 4 years) | Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study. |
| Secondary | Overall Survival | From the date of first treatment to the date of death for any cause (up to approximately 4 years) | Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment. |
| Secondary | Percentage of Participants With Adverse Events | Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years) | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Secondary | Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC) | Up to approximately 4 years | AUC is a measure of the drug or biologic concentration in the body following administration. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate in TKI-Naive Participants | Up to approximately 4 years | Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response Rate in TKI-Experienced Participants | Up to approximately 4 years | Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate | Up to approximately 4 years | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years) | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | months | MEDIAN |
| SECONDARY | Progression-Free Survival | From the day of first treatment until the first documented PD or death (up to approximately 4 years) | Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent. | months | MEDIAN |
| SECONDARY | Overall Survival | From the date of first treatment to the date of death for any cause (up to approximately 4 years) | Intent-to-Treat population, defined as all enrolled participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events | Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years) | Safety population, defined as enrolled participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC) | Up to approximately 4 years | Data were not collected for this outcome. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate in TKI-Naive Participants | TKI Naive | 42.3 | 95% Confidence Interval 23.35 to 63.08 | percentage of participants | |
| Best Overall Response Rate in TKI-Experienced Participants | TKI Experienced | 27.3 | 95% Confidence Interval 10.73 to 50.22 | percentage of participants | |
| Clinical Benefit Rate | TKI Naive | 73.1 | 95% Confidence Interval 52.21 to 88.43 | percentage of participants | |
| Clinical Benefit Rate | TKI Experienced | 54.5 | 95% Confidence Interval 32.21 to 75.61 | percentage of participants | |
| Duration of Response | TKI Naive | 9.5 | 95% Confidence Interval 5.7 to NA | months | |
| Duration of Response | TKI Experienced | 7.4 | 95% Confidence Interval 3.7 to NA | months | |
| Progression-Free Survival | TKI Naive | 18.2 | 95% Confidence Interval 15.5 to 29.3 | months | |
| Progression-Free Survival | TKI Experienced | 8.9 | 95% Confidence Interval 5.5 to 27.7 | months | |
| Overall Survival | TKI Naive | NA | 95% Confidence Interval 28.3 to NA | months | |
| Overall Survival | TKI Experienced | 14.4 | 95% Confidence Interval 8.2 to 29.1 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tyrosine Kinase Inhibitor (TKI) Naive | 26 | |
| Overall Study | STARTED | TKI Experienced | 25 | |
| Overall Study | COMPLETED | Tyrosine Kinase Inhibitor (TKI) Naive | 0 | |
| Overall Study | COMPLETED | TKI Experienced | 0 | |
| Overall Study | NOT COMPLETED | Tyrosine Kinase Inhibitor (TKI) Naive | 26 | |
| Overall Study | NOT COMPLETED | TKI Experienced | 25 |
Source ClinicalTrials.gov
Adverse events374
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 | Anaemia | Blood and lymphatic system disorders | TKI Naive | 9 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | TKI Experienced | 13 | 25 | |
| other | Leukopenia | Blood and lymphatic system disorders | TKI Naive | 3 | 26 | |
| other | Leukopenia | Blood and lymphatic system disorders | TKI Experienced | 1 | 25 | |
| other | Lymphopenia | Blood and lymphatic system disorders | TKI Naive | 5 | 26 | |
| other | Lymphopenia | Blood and lymphatic system disorders | TKI Experienced | 5 | 25 | |
| other | Neutropenia | Blood and lymphatic system disorders | TKI Naive | 2 | 26 | |
| other | Neutropenia | Blood and lymphatic system disorders | TKI Experienced | 0 | 25 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TKI Naive | 2 | 26 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TKI Experienced | 0 | 25 |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TKI Naive | ||
| Total, all-cause mortality | TKI Experienced | ||
| Total, other adverse events | TKI Naive | 26 | 26 |
| Total, other adverse events | TKI Experienced | 24 | 25 |
| Total, serious adverse events | TKI Naive | 16 | 26 |
| Total, serious adverse events | TKI Experienced | 18 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27460442 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TKI Naive vs TKI Experienced: serious adverse events |
Source 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/NCT01286753
GET https://conductscience.org/api/trials/v1/NCT01286753/events?page=2