The main purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus cobimetinib in participants with BRAF V600 mutated melanoma and to evaluate the safety and tolerability of this combination.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must be 18 years of age or above. All races and ethnicities are eligible and no upper limit of age is specified.
* Must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600 mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, meeting one of the following AJCC staging criteria: 1.) American Joint Committee on Cancer (AJCC) stage IV (Tany, Nany, M1a, b, or c); 2.) AJCC stage IIIB or IIIC with unresectable nodal/locoregional involvement.
* Adequate hepatic, renal, and bone marrow function with parameters obtained within 4 weeks prior to initiation of study treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Willing to give written informed consent per institutional guidelines and must be able to adhere to dose and visit schedules.
* Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥1 year.
* Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician.
* Treatment-naïve and previously treated patients will be included; however, patients may not have received a BRAF, Mitogen Activat…
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: Up to 12 months
Trial details
NCT IDNCT02721459
SponsorH. Lee Moffitt Cancer Center and Research Institute