Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
NCT ID: NCT03639246
Last Updated: 2023-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2018-12-06
2022-12-30
Brief Summary
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Detailed Description
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The Phase 1b portion of the study was a multicenter, 2-group, open-label design to evaluate the safety and tolerability of AVB-S6-500 combined with PLD or Pac in subjects with platinum-resistant recurrent ovarian cancer. The decision to enroll in the Phase 2 portion of the study was to be driven by the recommendation of a safe and tolerable dose of AVB-S6-500 in combination with each chemotherapy backbone; however, enrollment into the Phase 2 portion was not initiated per Sponsor decision. Given that sufficient data were obtained in the Phase 1b portion AVB-S6-500 + Pac group, the decision was made to pursue a randomized Phase 3 to further study the benefit of this combination versus paclitaxel alone in patients with platinum resistant ovarian cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 1b: AVB-S6-500+PLD
AVB-S6-500
AVB-S6-500 is experimental drug
Pegylated liposomal doxorubicin (PLD)
PLD is active comparator
Phase 1b: AVB-S6-500+Pac
AVB-S6-500
AVB-S6-500 is experimental drug
Paclitaxel (Pac)
Paclitaxel is active comparator
Phase 2: AVB-S6-500+PLD
AVB-S6-500
AVB-S6-500 is experimental drug
Pegylated liposomal doxorubicin (PLD)
PLD is active comparator
Phase 2: AVB-S6-500+Pac
AVB-S6-500
AVB-S6-500 is experimental drug
Paclitaxel (Pac)
Paclitaxel is active comparator
Phase 2: Placebo+PLD
Pegylated liposomal doxorubicin (PLD)
PLD is active comparator
Placebo
Placebo comparator
Phase 2: Placebo+Pac
Paclitaxel (Pac)
Paclitaxel is active comparator
Placebo
Placebo comparator
Interventions
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AVB-S6-500
AVB-S6-500 is experimental drug
Paclitaxel (Pac)
Paclitaxel is active comparator
Pegylated liposomal doxorubicin (PLD)
PLD is active comparator
Placebo
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Aravive, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Franke
Role: STUDY_DIRECTOR
Aravive, Inc.
Locations
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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
Countries
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Other Identifiers
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AVB500-OC-002
Identifier Type: -
Identifier Source: org_study_id
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