Trial Search Results

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

Phase 1B/2 randomized, controlled study of AVB-S6-500 in combination with PLD or Paclitaxel in patients with platinum-resistant recurrent ovarian cancer

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Aravive, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: AVB-S6-500
  • Drug: Paclitaxel (Pac)
  • Drug: Pegylated liposomal doxorubicin (PLD)
  • Other: Placebo

Phase:

Phase 1/Phase 2

Eligibility


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 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

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nimna Ranatunga
650-721-4070
Not Recruiting