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

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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
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Austin, Texas 78731
Phone: 281-863-2586
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Bedford, Texas 76022
Phone: 281-863-2586
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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...
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Dallas, Texas 75390
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Eugene, Oregon 97401
Phone: 281-863-2586
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Fort Worth, Texas 76104
Phone: 281-863-2586
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Oakland, California 94611
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Oklahoma City, Oklahoma 73104
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Palo Alto, California 94304
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2222 East Highland Avenue
Phoenix, Arizona 85016
Phone: 281-863-2586
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Roseville, California 95678
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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Saint Louis, Missouri 63110
Phone: 314-362-1705
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San Antonio, Texas 78229
Phone: 281-863-2586
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San Francisco, California 94115
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San Leandro, California 94577
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Santa Clara, California 95051
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Vallejo, California 94589
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Walnut Creek, California 94596
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