Statement: 50% of cohort 2 patients in the primary trial suffered Keratitis
Primary_evidence: Outcome Measurement:    Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel   DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade 3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs  30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of 20% to below the LLN; CS rash remaining CTCAE grade 3 for 5 days despite optimal treatment; CTCAE grade 3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade 3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by 7 days. Patients could have more than one DLT.   Time frame: Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant Results 1:    Arm/Group Title: AZD8931 160 mg bd   Arm/Group Description: Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle   Overall Number of Participants Analyzed: 6   Measure Type: Number   Unit of Measure: Number of Dose Limiting Toxicities  Total: 2   Eye disorders: Keratitis: 1   Eye disorders: Photophobia: 1   Gastrointestinal disorders: Diarrhoea: 1   Gastrointestinal disorders: Oesophagitis: 0   Infections and infestations: Rash pustular: 0 Results 2:    Arm/Group Title: AZD8931 120 mg bd   Arm/Group Description: Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle   Overall Number of Participants Analyzed: 2   Measure Type: Number   Unit of Measure: Number of Dose Limiting Toxicities  Total: 1   Eye disorders: Keratitis: 0   Eye disorders: Photophobia: 0   Gastrointestinal disorders: Diarrhoea: 1   Gastrointestinal disorders: Oesophagitis: 0   Infections and infestations: Rash pustular: 0