Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:December 3, 2018
End Date:December 2020
Contact:Aravive Clinical Trials
Email:clinicaltrials@aravive.com
Phone:281-810-6749

Use our guide to learn which trials are right for you!

A Phase 1b/2 Randomized, Controlled Study of AVB-S6-500 in Combination With Pegylated Liposomal Doxorubicin (PLD) or Paclitaxel (Pac) in Patients With Platinum-resistant Recurrent Ovarian Cancer

This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin
(PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The
phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD
or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind,
placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination
with PLD or Pac versus placebo plus PLD or Pac.


Inclusion Criteria:

- Age 18 years or older

- Histologically confirmed and documented recurrent ovarian, fallopian tube, and
peritoneal cancer.

- Platinum resistant disease, defined as progression within ≤ 6 months from completion
of most recent regimen and calculated from the date of the last administered dose of
platinum therapy

- Must have available archived tumor tissue OR if archived tissue is not available,
willing to provide a fresh tumor biopsy

- Must have radiologic imaging with a computerized tomography (CT) scan or magnetic
resonance imaging (MRI) within 4 weeks of enrollment

- Received at least 1 but not more than 3 therapy regimens, not including maintenance or
adjuvant therapy

- Must have ovarian cancer that is measurable according to RECIST 1.1

- ECOG performance status of 0-1

- Normal gastrointestinal (GI), bone marrow, liver and kidney function

- At least 28 days between termination of prior anti-cancer or hormonal therapy and
administration of AVB-S6-500

Exclusion Criteria:

- Primary platinum-refractory disease (defined as progression during the first platinum
regimen)

- Currently being treated with concurrent anti-cancer therapy or any other
interventional treatment or trial

- Received prior therapy with Pac or PLD in the recurrent setting, depending on
physician-chosen chemotherapy for this study

- Significant cardiac disease history

- Has other prior or concurrent malignancy within the past 5 years except adequately
treated basal cell skin cancer or carcinoma in situ of the cervix

- Symptomatic CNS metastasis or metastases

- Serious active infection requiring IV antibiotics and/or hospitalization at study
entry

- Has known human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C
We found this trial at
20
sites
San Antonio, Texas 78229
Phone: 281-863-2586
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Austin, Texas 78731
Phone: 281-863-2586
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bedford, Texas 76022
Phone: 281-863-2586
?
mi
from
Bedford, TX
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7738
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Eugene, Oregon 97401
Phone: 281-863-2586
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Fort Worth, Texas 76104
Phone: 281-863-2586
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Oakland, California 94611
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
2222 East Highland Avenue
Phoenix, Arizona 85016
Phone: 281-863-2586
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Roseville, California 95678
?
mi
from
Roseville, CA
Click here to add this to my saved trials
6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-362-1705
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Leandro, California 94577
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
Walnut Creek, California 94596
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials