It will also measure the immune response to tumor cells and characterize the therapeutic consequences of escalating
doses of the study drug.
Bleeding led to discontinuation of ticagrelor in about 7 percent of patients on the study drug, and dyspnea led to discontinuation
of the study drug in about 5 percent of patients on the drug.
(While few parents condone the
use of study drugs, neither do they do anything to stop it.
During Part 1 of the Study, certain dose
levels of The Study Drug will be evaluated in small groups of subjects for a certain period of time before giving a higher dose to the next group of subjects.
Sixteen of the 18 had received two doses, one had received one dose, and one had received three doses
of the study drug before symptoms occurred.
The purpose of Part 2 is to determine if the dose and treatment
cycle of the Study Drug chosen from Part 1 is effective for treating specific types of cancer while gathering additional safety data.
The main purpose of this study is to find out more about the side
effects of the study drug, MM - 121, when combined with the study drugs, docetaxel or pemetrexed, and to learn if cancer cell growth (disease progression) is delayed in people taking MM - 121 with docetaxel or pemetrexed.
• Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half - lives (whichever is shorter) before the first
dose of study drug.
The tablet will contain either a lower dose
of the study drug, a higher dose of the study drug, or a placebo, depending on which group you are assigned to.
The study is sponsored by Incyte Corporation (the Sponsor) This study has 2 parts; the purpose of Part 1 is to determine what dose
of the Study Drug is safe and well tolerated.
Exclusion Criteria: • Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration
of study drug.
All previous therapies must have completed ≥ 3 weeks (21 days) prior to first dose
of study drug.