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Association details:
| Biomarker: | BRAF V600 |
|---|---|
| Cancer: | Melanoma |
| Drug: | Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
02/17/2012
Excerpt:
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
Source:
Title:
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
Excerpt:
...- Participants with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAF V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a Deoxyribonucleic acid (DNA) sequencing method, and who have...
Trial ID:
Source:
Title:
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Excerpt:
...- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have...
Trial ID:
More C2 evidence
Source:
Title:
The Safety and Efficacy Study of Vemurafenib (CT) Compared With Vemurafenib (Zelbolaf®) in Advanced Patients Harboring the V600 BRAF Mutation
Excerpt:
...- Signed written informed consent - Recheck the results of histological studies and paraffin blocks - Histologically confirmed cancer that is either Stage IIIc (unresectable) or ---Stage IV (metastatic), and determined to be BRAF V600E or V600K mutation-positive by the local laboratory. ...
Source:
Title:
A multicenter phase II study evaluating the effect and tolerability of vemurafenib in combination with Pegylated Interferon and Interleukin-2 in patients with metastatic melanoma positive for the BRAF-mutation En multicenter fase II undersøgelse af vemurafenib i kombination med Pegyleret Interferon og Interleukin-2 til patienter med BRAF-muteret metastatisk malignt melanom
Excerpt:
...•Histologically verified unresectable stage III or stage IV melanoma with documented BRAF V600 mutation determined by the cobas® 4800 BRAF mutation test •Age between 18 and 70 •ECOG performance status (PS) 0-2 •Patients must have measurable target lesions disease as defined by RECIST v1.1 •Prior medical treatment for metastatic melanoma is allowed, except previous treatment with BRAF-inhibitor and IL-2 based immunotherapy •Adequate cardiac function (less or equal to NYHA II). ...
Trial ID:
Source:
Title:
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
Excerpt:
...- Positive BRAF V600E mutation result (by Roche CoDx test)...
Trial ID:
Source:
Title:
HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma
Excerpt:
...- Confirmed and measurable metastatic melanoma with the BRAFV600 mutation....
Trial ID:
Source:
Title:
A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
Excerpt:
...- Patients must have histologically confirmed diagnosis of Stege IV metastic melanoma positive for BRAF V600E mutation by either the COBAS test or other CLIA approved assay....
Trial ID:
Source:
Title:
A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
Excerpt:
...- Participants with age greater than or equal to (>=) 18 years with either unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF...
Trial ID:
Source:
Title:
An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
Excerpt:
...- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib....
Trial ID:
Source:
Title:
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Excerpt:
...- Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected...
Trial ID:
Source:
Title:
A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
Excerpt:
...- Positive BRAF V600 mutation result determined by a designated laboratory using the Cobas 4800 BRAF V600 Mutation Test...
Trial ID:
Source:
Title:
A Pilot Study of Trientine With Vemurafenib for the Treatment BRAF Mutated Metastatic Melanoma
Excerpt:
...Histologic diagnosis of unresectable stage IIIC or stage IV melanoma that is BRAF V600 mutation positive 4....
Trial ID:
Source:
Title:
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
Excerpt:
...- Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib...
Trial ID:
Source:
Title:
Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies
Excerpt:
...- Participants with either unresectable or metastatic melanoma positive for the BRAF^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for whom vemurafenib is an accepted standard of care or where there is...
Trial ID:
Source:
Title:
Safety Study of PLX4032 in Patients With Solid Tumors
Excerpt:
...- Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032...
Trial ID:
Source:
Title:
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Excerpt:
...- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)...
Trial ID:
Source:
Title:
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Excerpt:
...- BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)...
Trial ID:
Source:
Title:
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
Excerpt:
...- Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E, as detected by DNA sequencing of exon 15 performed at a centralized laboratory...
Trial ID:
Source:
Title:
Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma
Excerpt:
...- Melanoma must be documented to contain a BRAF V600 mutation by a CLIA approved assay...
Trial ID:
Source:
Title:
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Excerpt:
...- Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing method...
Trial ID:
Source:
Title:
Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases
Excerpt:
...- Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations....
Trial ID:
Source:
Title:
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Excerpt:
...- Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have...
Trial ID:
Source:
Title:
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Excerpt:
...- Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have...
Trial ID:
Source:
Title:
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
Excerpt:
...- Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test...
Trial ID:
Source:
Title:
Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases
Excerpt:
...BRAFV600 mutation positive (cobas 4800 BRAFV600 mutation test) 4....
Trial ID:
Source:
Title:
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
Excerpt:
...- Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)...
Trial ID:
Source:
Title:
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Excerpt:
...- positive for BRAF V600E mutation...
Trial ID:
Source:
Title:
A Study of RO5185426 in Patients With Metastatic Melanoma
Excerpt:
...- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test...
Trial ID:
Source:
Title:
Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
Excerpt:
...- A confirmed EBRAFV600E or KBRAFV600K mutation....
Trial ID:
Source:
Title:
A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Excerpt:
...- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have...
Trial ID:
Source:
Title:
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
Excerpt:
...- positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)...
Trial ID:
Source:
Title:
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
Excerpt:
...Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer); 3....
Trial ID:
Less C2 evidence
Source:
Title:
Vemurafenib: First-in-Class BRAF-Mutated Inhibitor for the Treatment of Unresectable or Metastatic Melanoma
Excerpt:
Mutated BRAF is a new target for the treatment of advanced melanoma and provides an important opportunity for new therapies. Vemurafenib is indicated as an option for first-line therapy in patients with unresectable or metastatic melanoma with BRAF V600E mutation. Vemurafenib has shown increases in overall and progression-free survival compared with dacarbazine
