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

Purpose

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.

Condition

  • Ovarian Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1b: AVB-S6-500+PLD
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Pegylated liposomal doxorubicin (PLD)
    PLD is active comparator
    Other names:
    • Doxil
Experimental
Phase 1b: AVB-S6-500+Pac
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Paclitaxel (Pac)
    Paclitaxel is active comparator
    Other names:
    • Taxol
Experimental
Phase 2: AVB-S6-500+PLD
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Pegylated liposomal doxorubicin (PLD)
    PLD is active comparator
    Other names:
    • Doxil
Experimental
Phase 2: AVB-S6-500+Pac
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Paclitaxel (Pac)
    Paclitaxel is active comparator
    Other names:
    • Taxol
Active Comparator
Phase 2: Placebo+PLD
  • Drug: Pegylated liposomal doxorubicin (PLD)
    PLD is active comparator
    Other names:
    • Doxil
  • Other: Placebo
    Placebo comparator
Active Comparator
Phase 2: Placebo+Pac
  • Drug: Paclitaxel (Pac)
    Paclitaxel is active comparator
    Other names:
    • Taxol
  • Other: Placebo
    Placebo comparator

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02214

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Christin Whalen
617-582-7738
cwhalen@partners.org

More Details

NCT ID
NCT03639246
Status
Recruiting
Sponsor
Aravive, Inc.

Study Contact

Aravive Clinical Trials
281-810-6749
clinicaltrials@aravive.com