Trial · NCT02034110
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
NCT02034110, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2023-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers. Trials, record NCT02034110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02034110
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
- NCT number
- NCT02034110
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 206 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cancer
- Interventions
- Dabrafenib, Trametinib
- First posted
- 2014-01-13
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2013-001705-87
- Results first posted
- 2023-08-21
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (response assessment criteria (CR, PR, and minor response \[MR\]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population. |
| Primary | Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population. |
| Primary | Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease \[MRD\], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population. |
| Primary | Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population. |
| Secondary | Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort | From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21) | For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment. |
| Secondary | Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort | From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21) | For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary analysis cohort | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohort combined | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort | From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary analysis cohort | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort | From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis. | Weeks | MEDIAN |
| SECONDARY | Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort | From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21) | ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis. | Weeks | MEDIAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | Anaplastic Thyroid Cancer (ATC) | Investigator assessment @ up to 78 months | 56 | 95% Confidence Interval 38.1 to 72.1 | Percentage of Participants |
| Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | Anaplastic Thyroid Cancer (ATC) | Investigator assessment @ up to 92 months | 56 | 95% Confidence Interval 38.1 to 72.1 | Percentage of Participants |
| Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | Anaplastic Thyroid Cancer (ATC) | Independent radiology review @ up to 78 months | 53 | 95% Confidence Interval 35.5 to 69.6 | Percentage of Participants |
| Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort | Anaplastic Thyroid Cancer (ATC) | Independent radiology review @ up to 92 months | 53 | 95% Confidence Interval 35.5 to 69.6 | Percentage of Participants |
| Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | Biliary Tract Cancer (BTC) | Investigator assessment @ up to 78 months | 53 | 95% Confidence Interval 37.7 to 68.8 | Percentage of Participants |
| Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | Biliary Tract Cancer (BTC) | Investigator assessment @ up to 92 months | 53 | 95% Confidence Interval 37.7 to 68.8 | Percentage of Participants |
| Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | Biliary Tract Cancer (BTC) | Independent radiology review @ up to 78 months | 47 | 95% Confidence Interval 31.2 to 62.3 | Percentage of Participants |
| Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort | Biliary Tract Cancer (BTC) | Independent radiology review @ up to 92 months | 47 | 95% Confidence Interval 31.2 to 62.3 | Percentage of Participants |
| Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort | Gastrointestinal Stromal Tumor (GIST) | Investigator assessment @ 78 months | 0 | 95% Confidence Interval NA to NA | Percentage of Participants |
| Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort | Gastrointestinal Stromal Tumor (GIST) | Investigator assessment @ 92 months | 0 | 95% Confidence Interval NA to NA | Percentage of Participants |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anaplastic Thyroid Cancer (ATC) | 36 | |
| Overall Study | STARTED | Biliary Tract Cancer (BTC) | 43 | |
| Overall Study | STARTED | Gastrointestinal Stromal Tumor (GIST) | 1 | |
| Overall Study | STARTED | Low Grade (WHO G1/G2) Glioma (LGG) | 13 | |
| Overall Study | STARTED | High Grade (WHO G3/G4) Glioma (HGG) | 45 | |
| Overall Study | STARTED | Adenocarcinoma of the Small Intestine (ASI) | 3 | |
| Overall Study | STARTED | Hairy Cell Leukemia (HCL) | 55 | |
| Overall Study | STARTED | Multiple Myeloma (MM) | 10 | |
| Overall Study | Primary Analysis Cohort | Anaplastic Thyroid Cancer (ATC) | 15 | |
| Overall Study | Primary Analysis Cohort | Biliary Tract Cancer (BTC) | 18 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events6,656
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 | Anaplastic Thyroid Cancer (ATC) (On-Treatment) | 12 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | Biliary Tract Cancer (BTC) (On-Treatment) | 10 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Gastrointestinal Stromal Tumor (GIST) (On-Treatment) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment) | 4 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment) | 9 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Adenocarcinoma of the Small Intestine (ASI) (On-Treatment) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Hairy Cell Leukemia (HCL) (On-Treatment) | 10 | 55 | |
| other | Anaemia | Blood and lymphatic system disorders | Multiple Myeloma (MM) (On-Treatment) | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up) | 0 |
1 to 10 of 6,656Source ClinicalTrials.gov
See all 6,656 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anaplastic Thyroid Cancer (ATC) (On-Treatment) | 6 | 36 |
| Total, all-cause mortality | Biliary Tract Cancer (BTC) (On-Treatment) | 6 | 43 |
| Total, all-cause mortality | Gastrointestinal Stromal Tumor (GIST) (On-Treatment) | 0 | 1 |
| Total, all-cause mortality | Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment) | 1 | 13 |
| Total, all-cause mortality | High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment) | 2 | 45 |
| Total, all-cause mortality | Adenocarcinoma of the Small Intestine (ASI) (On-Treatment) | 0 | 3 |
| Total, all-cause mortality | Hairy Cell Leukemia (HCL) (On-Treatment) | 4 | 55 |
| Total, all-cause mortality | Multiple Myeloma (MM) (On-Treatment) | 1 | 10 |
| Total, all-cause mortality | Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up) | 18 | 30 |
| Total, all-cause mortality | Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up) | 28 | 37 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers8
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
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GET https://conductscience.org/api/trials/v1/NCT02034110
GET https://conductscience.org/api/trials/v1/NCT02034110/registered?page=2