disease study updates Professor Michael J Seckl GCIG Chicago - PowerPoint PPT Presentation

Gestational Trophoblastic disease study updates Professor Michael J Seckl GCIG Chicago meeting Jun ‘17

GOG-0275: A PHASE III RANDOMIZED TRIAL OF PULSE ACTINOMYCIN-D VERSUS MULTI-DAY METHOTREXATE FOR THE TREATMENT OF LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA Study Chair: Julian Schink, MD Arm Regimen 1 : IV actinomycin-D (1.25mg/m 2 ) every 14 days. (2mg max dose) R Eligible A patients: N Arm Regimen 2 : Low-risk D • IV methotrexate (0.4 mg/kg) daily for GTN O 5 days every 14 days. (25mg max daily FIGO M dose) Score 0-6 I OR Z • IM methotrexate(50mg) on Days 1, 3, 5, 7 E (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Opened June ‘12. 57/381 recruited: closed Sep ‘16

Phase II trial of anti-endoglin antibody (TRC105) without or with bevacizumab in relapsed high risk GTN TRC105 CR 30 patients Continued for 4 cycles TRC105 + Single agent PR bevacizumab TRC105 TRC105 + Single agent Inclusion criteria: NR PR bevacizumab bevacizumab • High risk GTN • Elevated hCG or Measurable PSTT/ETT Opening Nov ‘16 •  1 prior multi agent regimen • PS  1

Phase II trial of anti-endoglin antibody (TRC105) without or with bevacizumab in relapsed high risk GTN Primary Endpoint: - ORR toTRC105  Bevacizumab Secondary Endpoints: - PFS - ORR to bev in patients refractory to TRC105 - evaluate formation of anti-TRC105 antibodies - evaluate PK of TRC105 and bev - assess toxicity - assess angiogenic biomarkers 4 patients recruited: 1 CR and 2 PD and 1 starting