Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with 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 where the participant has no acceptable standard treatment options.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Vemurafenib+Itraconazole | Experimental | Part 1: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with itraconazole orally once in the morning from Days 21 to 40 (Period B).\nPart 2: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with rifampin orally once in the morning from Days 21 to 40 (Period B). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve From Time 0 to 12 Hours Postdose (AUC0-12) | Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 | |
| Maximum observed concentration (Cmax) | Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 | |
| Time to maximum concentration (Tmax) | Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 28 days after last dose of study treatment (last dose = Day 40) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary Crowley Medical Research Center | Dallas | Texas | 75230 | United States | ||
| Rambam Health Care Campus; Oncology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifampin | Drug | Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days. |
|
| Vemurafenib | Drug | Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days. |
|
| Haifa |
| 3109601 |
| Israel |
| Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | 9112000 | Israel |
| Tel Aviv Sourasky Medical Center; Pharmacy | Tel Aviv | 64239 | Israel |
| Republican Clinical Oncologic Dispensary of Republic Of Tatarstan | Kazan' | 420029 | Russia |
| FSBSI "N. N. Blokhin Russian Cancer Research Center" | Moscow | 115478 | Russia |
| St. Petersburg Oncology Hospital | Saint Petersburg | 198255 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center; Gastroenterology | Seoul | 135-710 | South Korea |
| Asan Medical Center; Division of Oncology | Seoul | 138-736 | South Korea |
| Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept. | Seoul | South Korea |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided