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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT03639246

Run by

Aravive, Inc.

People needed

53

Starts

2018-12-06

Expected to finish

2022-12-30

Last updated by the study team

2023-02-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 first dose of study drug
• 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

You may not qualify if…

• Primary platinum-refractory disease (defined as progression during the first platinum regimen or within 4 weeks of completion of 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 previous or current human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C
• Has had paracentesis for ascites within 3 months

Where it is running

• Arizona Oncology — Phoenix, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Kaiser Permanente Roseville — Roseville, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• Kaiser Permanente Vallejo — Vallejo, California, United States
• Kaiser Permanente Walnut Creek — Walnut Creek, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• OUHSC-Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• Texas Oncology - Austin Central — Austin, Texas, United States
• Texas Oncology - Fort Worth — Fort Worth, Texas, United States
• Texas Oncology - San Antonio Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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