A Phase I Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) in Patients With Advanced Solid Tumors and Normal or Varying Degrees of Hepatic Impairment
Clinical Trial Information
Trial Contact: Morales, Leticia; Pelley, Jennifer; Rompola, Melissa; Walton, Sherri; Jobson, Gillian S
IRB No: WIRB 1167203
Protocol Abbrev: TRIO MDV3800-02
Principal Investigator: Rebecca L. Moroose, MD
Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Hajdenberg, Julio MD; Johnson, Tirrell MD; Landau, Daniel MD; Neely, Lindsey ARNP; Rostorfer, Regan MD; Shah, Nikita MD; Tseng, Jennifer MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: TRIO 028
Applicable Disease Sites: skin, breast, ovarian, lung, GI, GU
Therapies Involved: Talazoparib
To investigate the effect of mild, moderate or severe hepatic impairment on the PK of talazoparib following daily oral dosing for 22 consecutive days, in patients with advanced solid tumors.
Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator (i.e. patients who received and failed standard therapy or with no effective standard therapy available).
Expected life expectancy of ≥ 3 months.
Hepatic function at screening and enrollment as defined by the NCI-ODWG criteria for hepatic impairment:
• Normal hepatic function (Group A): Total bilirubin (TB) and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN) or
• Mild hepatic dysfunction (Group B): TB ≤ ULN and AST > ULN or TB> 1.0 to 1.5 x ULN and any AST value , or
• Moderate hepatic dysfunction (Group C): TB > 1.5 to 3.0 x ULN and any AST value or
• Severe hepatic dysfunction (Group D): TB > 3 x ULN and any AST value.
Each patient’s hepatic function classification for the study will be based on the assessment made at enrollment, if screening classification is different. No distinction will be made between hepatic impairment due to metastases and due to other causes.