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.
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
Interventions
Drug | Synonyms | Arms |
---|
AVB-S6-500 | | Phase 1b: AVB-S6-500+PLD |
Paclitaxel (Pac) | Taxol | Phase 1b: AVB-S6-500+Pac |
Pegylated liposomal doxorubicin (PLD) | Doxil | Phase 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
Name | Type | Description | Interventions |
---|
Phase 1b: AVB-S6-500+PLD | Experimental | | - AVB-S6-500
- Pegylated liposomal doxorubicin (PLD)
|
Phase 1b: AVB-S6-500+Pac | Experimental | | - AVB-S6-500
- Paclitaxel (Pac)
|
Phase 2: AVB-S6-500+PLD | Experimental | | - AVB-S6-500
- Pegylated liposomal doxorubicin (PLD)
|
Phase 2: AVB-S6-500+Pac | Experimental | | - AVB-S6-500
- Paclitaxel (Pac)
|
Phase 2: Placebo+PLD | Active Comparator | | - Pegylated liposomal doxorubicin (PLD)
|
Phase 2: Placebo+Pac | Active Comparator | | |
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 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
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: | Active, not recruiting |
Lead Sponsor: | Aravive, Inc. |
Trial Keywords
- Ovarian cancer
- Platinum resistant
Last Updated
January 6, 2021