{"groups":[{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation \\[DE\\] cohort).","id":"FG000","title":"Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG001","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG002","title":"Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG003","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG004","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG005","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG006","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG007","title":"Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG008","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG009","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"FG010","title":"Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily"},{"description":"Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"FG011","title":"TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"FG012","title":"NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"FG013","title":"CRC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"FG014","title":"MEL: Pimasertib 60mg and SAR245409 70mg Once Daily"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"19"},{"groupId":"FG007","numSubjects":"14"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"4"},{"groupId":"FG011","numSubjects":"26"},{"groupId":"FG012","numSubjects":"24"},{"groupId":"FG013","numSubjects":"18"},{"groupId":"FG014","numSubjects":"15"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"19"},{"groupId":"FG007","numSubjects":"14"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"4"},{"groupId":"FG011","numSubjects":"26"},{"groupId":"FG012","numSubjects":"24"},{"groupId":"FG013","numSubjects":"18"},{"groupId":"FG014","numSubjects":"15"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Study had a 4-day Drug-Drug Interaction (DDI) period, within 1 week prior to Day 1 Cycle 1, to assess possible interaction only in selected subjects where in SAR245409 and Pimasertib were administered alone on Day 1 and Day 3, respectively.","recruitmentDetails":"First subject (informed consent): May 2011. Study completion date: Apr 2015. A total of 192 subjects were screened and 146 subjects entered the trial and received the investigational medicinal product (IMP)."}