Clinical Trials /

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

NCT03639246

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: AVB500-OC-002
  • NCT ID: NCT03639246

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
AVB-S6-500Phase 1b: AVB-S6-500+PLD
Paclitaxel (Pac)TaxolPhase 1b: AVB-S6-500+Pac
Pegylated liposomal doxorubicin (PLD)DoxilPhase 1b: AVB-S6-500+PLD

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.

Trial Arms

NameTypeDescriptionInterventions
Phase 1b: AVB-S6-500+PLDExperimental
  • AVB-S6-500
  • Pegylated liposomal doxorubicin (PLD)
Phase 1b: AVB-S6-500+PacExperimental
  • AVB-S6-500
  • Paclitaxel (Pac)
Phase 2: AVB-S6-500+PLDExperimental
  • AVB-S6-500
  • Pegylated liposomal doxorubicin (PLD)
Phase 2: AVB-S6-500+PacExperimental
  • AVB-S6-500
  • Paclitaxel (Pac)
Phase 2: Placebo+PLDActive Comparator
  • Pegylated liposomal doxorubicin (PLD)
Phase 2: Placebo+PacActive Comparator
  • Paclitaxel (Pac)

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:6 months
Safety Issue:
Description:Measured by the number of patients with AEs in Phase 1 portion of the study.

Secondary Outcome Measures

Measure:Pharmacokinetics: AUC
Time Frame:18 months
Safety Issue:
Description:Area under the AVB-S6-500 concentration-time curve.
Measure:Pharmacokinetics: Cmax
Time Frame:18 months
Safety Issue:
Description:Maximum observed AVB-S6-500 concentration.
Measure:Pharmacokinetics: Tmax
Time Frame:18 months
Safety Issue:
Description:Time of maximum observed AVB-S6-500 concentration.
Measure:Pharmacokinetics: t1/2
Time Frame:18 months
Safety Issue:
Description:Apparent terminal half-life of AVB-S6-500.
Measure:Pharmacodynamic marker assessment
Time Frame:18 months
Safety Issue:
Description:Change from the baseline in GAS6 serum levels.
Measure:Anti-drug antibody (ADA) titers
Time Frame:18 months
Safety Issue:
Description:Change from baseline in ADA titer.
Measure:Objective response rate
Time Frame:18 months
Safety Issue:
Description:Proportion of subjects who have a partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as well as Gynecologic Cancer Intergroup (GCIG) cancer antigen (CA)-125 criteria.
Measure:Disease control rate
Time Frame:18 months
Safety Issue:
Description:Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Measure:Duration of response (DOR)
Time Frame:18 months
Safety Issue:
Description:Measured from the date of partial or complete response to therapy until the cancer progresses.
Measure:Overall survival
Time Frame:30 months
Safety Issue:
Description:Time following the treatment until death.
Measure:CA-125 response rate
Time Frame:18 months
Safety Issue:
Description:Proportion of subjects with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to baseline CA-125 serum levels.
Measure:Quality of Life(QOL)
Time Frame:18 months
Safety Issue:
Description:Subject QOL will be assessed every 8 weeks during treatment using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aravive Biologics

Trial Keywords

  • Ovarian cancer
  • Platinum resistant

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