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Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Aravive Biologics, Inc.
 
Acronym KP IRB No.
1336283
 
Study Type Phase
Clinical Trial Phase I
 
Study Population Description
Individuals with platinum-resistant recurrent ovarian cancer.
 
Purpose
The primary objective of this study is to evaluate the safety and tolerability of AVB-S6-500 (AVB) in c ombination with pegylated liposomal doxorubicin (PLD) or paclitaxel (Pac) in platinum resistant recurrent ovarian cancer patients.
 
Detailed Description
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.
 
Gender Age Limit
Male & Female
 
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
  • 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 active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment
  • Has known human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C

 
Keywords and/or Specific Medical Conditions
  • Adnexal Diseases
  • Molecular Mechanisms of Pharmacological Action
  • Albumin-Bound Paclitaxel
  • Neoplasms
  • Antibiotics, Antineoplastic
  • Neoplasms by Histologic Type
  • Antimitotic Agents
  • Neoplasms by Site
  • Antineoplastic Agents
  • Neoplasms, Glandular and Epithelial
  • Antineoplastic Agents, Phytogenic
  • Ovarian cancer
  • Doxorubicin
  • Ovarian Diseases
  • Endocrine Gland Neoplasms
  • Ovarian Neoplasms
  • Endocrine System Diseases
  • Paclitaxel
  • Enzyme Inhibitors
  • Platinum resistant
  • Genital Diseases, Female
  • Topoisomerase II Inhibitors
  • Genital Neoplasms, Female
  • Topoisomerase Inhibitors
  • Gonadal Disorders
  • Tubulin Modulators
  • Liposomal doxorubicin
  • Urogenital Neoplasms
  • Mitosis Modulators
  • Oncology (Adult)
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Michael Bookman, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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