A Phase 3, randomized, double-blind, adaptive, placebo/paclitaxel-controlled study of AVB-S6-500 in combination with paclitaxel in patients with platinum-resistant recurrent ovarian cancer. (GOG 3059)

Purpose

To evaluate the effect of AVB-S6-500 plus Paclitaxel versus placebo and Paclitaxel on progression-free survival based on response evaluation criteria in solid tumors criteria, in subjects with platinum-resistant ovarian cancer.

Criteria

1.      Confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.

2.      Platinum-resistant disease (defined as progression within 6 months from completion of most recent platinum-containing regimen and calculated from the last date of platinum therapy).

3.      Received at least one but no more than four prior therapy regimens since ovarian cancer diagnosis.

4.      Normal GI function.

5.      Adequate bone marrow function.

6.      Adequate liver and kidney function.

You cannot

1.       Have tumors in the breast or bone.

2.       Have primary platinum-refractory disease (defined as progression during or within four weeks of completion of first platinum regimen).

3.       Have clinically significant heart disease.

4.       Have history of or present central nervous system disorders.

5.       Have a nonhealing wound, ulcer, or bone fracture.

6.       Have active infection.

7.       Have HIV or Hepatitis B or C.

Details

1.       Standard of care chemotherapy given on days 1, 8, and 15 of each 28-day cycle. Study drug or placebo will be given on days 1 and 15 of each 28-day treatment cycle.

2.       Lab drawn at visits with standard of care labs.

3.       Imaging done every 8 weeks.

Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com



Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: Western
IRB Number:
Trial Type: NA
Sponsor: Aravive