Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04940052 | Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 153 | — | — | Nov 15, 2021 | May 17, 2027 | Jun 4, 2026 | 41 | United States, Argentina +9 |
Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025).
| Arm | Type | Description |
|---|---|---|
| Dabrafenib plus Trametinib | EXPERIMENTAL | Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
| Dabrafenib Placebo plus Trametinib Placebo | PLACEBO_COMPARATOR | Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
| Name | Type | Description |
|---|---|---|
| Dabrafenib | DRUG | Dabrafenib 150 mg capsule administered orally twice a day (BID) |
| Trametinib | DRUG | Trametinib 2 mg tablet administered once a day (QD) |
| Trametinib Placebo | DRUG | matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD) |
| Dabrafenib placebo | DRUG | matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID) |
Key Inclusion Criteria: * Signed informed consent * Male or female ≥ 18 years of age at time of informed consent * Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid carcinoma * Radioactive-iodine refractory disease * BRAF V600E mutation-positive tumor...