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 2:

• IV methotrexate (0.4 mg/kg) daily for

5 days every 14 days. (25mg max daily dose) OR

• IM methotrexate(50mg) on Days 1, 3, 5, 7

(4 doses per cycle) with Leucovorin (15mg)

• n Days 2, 4, 6, 8. Repeat every 14 days.

Arm Regimen 1: IV actinomycin-D (1.25mg/m2) every 14 days. (2mg max dose)

Eligible patients: Low-risk GTN FIGO Score 0-6

R A N D O M I Z E

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

Inclusion criteria:

• High risk GTN
• Elevated hCG or

Measurable PSTT/ETT

• 1 prior multi agent regimen
• PS  1

Single agent TRC105 TRC105 + bevacizumab Single agent bevacizumab TRC105

Continued for 4 cycles

TRC105 + bevacizumab CR PR NR PR

30 patients Opening Nov ‘16

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

Phase II trial of anti-endoglin antibody (TRC105) without or with bevacizumab in relapsed high risk GTN

4 patients recruited: 1 CR and 2 PD and 1 starting