Ovarian CancerPhase 1NCT03639246
Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
A Phase 1 study testing AVB-S6-500, Paclitaxel (Pac) and Pegylated liposomal doxorubicin (PLD) in people with Ovarian Cancer, run by Aravive, Inc. at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- AVB-S6-500, Paclitaxel (Pac) and Pegylated liposomal doxorubicin (PLD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 16 sitesUnited States
- Study dates
- 6 Dec 2018to 30 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Texas Oncology - Austin Central
Austin, Texas, 78731
Massachusetts General Hospital
Boston, Massachusetts, 02214
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
Kaiser Permanente Oakland
Oakland, California, 94611
OUHSC-Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Arizona Oncology
Phoenix, Arizona, 85016
Kaiser Permanente Roseville
Roseville, California, 95661
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
Kaiser Permanente San Francisco
San Francisco, California, 94115
Kaiser Permanente Santa Clara
Santa Clara, California, 95051
Washington University
St Louis, Missouri, 63110
Arizona Oncology Associates
Tucson, Arizona, 85711
Kaiser Permanente Vallejo
Vallejo, California, 94589
Kaiser Permanente Walnut Creek
Walnut Creek, California, 94596
About this study
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
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.
Read the detailed description
While this study was planned as two-part study consisting of a Phase 1b and a Phase 2 portion, the sponsor decided not to proceed with the Phase 2 portion.
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
- Ovarian Cancer
- Being tested
- AVB-S6-500, Paclitaxel (Pac), Pegylated liposomal doxorubicin (PLD), Placebo
- Keywords
- Ovarian cancer, Platinum resistant
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVB-S6-500Drug
AVB-S6-500 is experimental drug
Paclitaxel (Pac)Drug
Also called Taxol
Paclitaxel is active comparator
Pegylated liposomal doxorubicin (PLD)Drug
Also called Doxil
PLD is active comparator
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: AVB-S6-500+PLD | Experimental | Not described Receives: Drug: AVB-S6-500; Drug: Pegylated liposomal doxorubicin (PLD) |
| Phase 1b: AVB-S6-500+Pac | Experimental | Not described Receives: Drug: AVB-S6-500; Drug: Paclitaxel (Pac) |
| Phase 2: AVB-S6-500+PLD | Experimental | Not described Receives: Drug: AVB-S6-500; Drug: Pegylated liposomal doxorubicin (PLD) |
| Phase 2: AVB-S6-500+Pac | Experimental | Not described Receives: Drug: AVB-S6-500; Drug: Paclitaxel (Pac) |
| Phase 2: Placebo+PLD | Active comparator | Not described Receives: Drug: Pegylated liposomal doxorubicin (PLD); Other: Placebo |
| Phase 2: Placebo+Pac | Active comparator | Not described Receives: Drug: Paclitaxel (Pac); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured by the number of patients with AEs in Phase 1 portion of the study.
Measured: 6 months
Anti-tumor activity of AVB-S6-500 in combination with PLD
Measured by progression free survival (PFS) in patients receiving AVB-S6-500+PLD versus patients receiving Placebo+PLD in Phase 2 portion of the study.
Measured: 18 months
Anti-tumor activity of AVB-S6-500 in combination with Pac
Measured by progression free survival (PFS) in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac in Phase 2 portion of the study.
Measured: 18 months
Secondary outcomes (12)
Pharmacokinetics: AUC
Area under the AVB-S6-500 concentration-time curve.
Measured: 18 months
Pharmacokinetics: Cmax
Maximum observed AVB-S6-500 concentration.
Measured: 18 months
Pharmacokinetics: Tmax
Time of maximum observed AVB-S6-500 concentration.
Measured: 18 months
Pharmacokinetics: t1/2
Apparent terminal half-life of AVB-S6-500.
Measured: 18 months
Pharmacodynamic marker assessment
Change from the baseline in GAS6 serum levels.
Measured: 18 months
Anti-drug antibody (ADA) titers
Change from baseline in ADA titer.
Measured: 18 months
Objective response rate
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.
Measured: 18 months
Disease control rate
Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Measured: 18 months
Duration of response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses.
Measured: 18 months
Overall survival
Time following the treatment until death.
Measured: 30 months
CA-125 response rate
Proportion of subjects with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to baseline CA-125 serum levels.
Measured: 18 months
Quality of Life(QOL)
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start6 Dec 2018
- Primary completion8 Jan 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aravive, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Franke, Study director, Aravive, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639246
- Sponsor's protocol ID
- AVB500-OC-002
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2018
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03639246
- Acronym / sponsor ID
- AVB500-OC-002
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Platinum resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Aravive, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While this study was planned as two-part study consisting of a Phase 1b and a Phase 2 portion, the sponsor decided not to proceed with the Phase 2 portion.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: AVB-S6-500+PLD | Experimental | Drug: AVB-S6-500, Drug: Pegylated liposomal doxorubicin (PLD) |
| Phase 1b: AVB-S6-500+Pac | Experimental | Drug: AVB-S6-500, Drug: Paclitaxel (Pac) |
| Phase 2: AVB-S6-500+PLD | Experimental | Drug: AVB-S6-500, Drug: Pegylated liposomal doxorubicin (PLD) |
| Phase 2: AVB-S6-500+Pac | Experimental | Drug: AVB-S6-500, Drug: Paclitaxel (Pac) |
| Phase 2: Placebo+PLD | Active comparator | Drug: Pegylated liposomal doxorubicin (PLD), Other: Placebo |
| Phase 2: Placebo+Pac | Active comparator | Drug: Paclitaxel (Pac), Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVB-S6-500AVB-S6-500 is experimental drug | Drug | Phase 1b: AVB-S6-500+PLD, Phase 1b: AVB-S6-500+Pac, Phase 2: AVB-S6-500+PLD, Phase 2: AVB-S6-500+Pac |
| Paclitaxel (Pac)Also: TaxolPaclitaxel is active comparator | Drug | Phase 1b: AVB-S6-500+Pac, Phase 2: AVB-S6-500+Pac, Phase 2: Placebo+Pac |
| Pegylated liposomal doxorubicin (PLD)Also: DoxilPLD is active comparator | Drug | Phase 1b: AVB-S6-500+PLD, Phase 2: AVB-S6-500+PLD, Phase 2: Placebo+PLD |
| PlaceboPlacebo comparator | Other | Phase 2: Placebo+PLD, Phase 2: Placebo+Pac |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 6 months
Measured by the number of patients with AEs in Phase 1 portion of the study.
Anti-tumor activity of AVB-S6-500 in combination with PLD
Time frame: 18 months
Measured by progression free survival (PFS) in patients receiving AVB-S6-500+PLD versus patients receiving Placebo+PLD in Phase 2 portion of the study.
Anti-tumor activity of AVB-S6-500 in combination with Pac
Time frame: 18 months
Measured by progression free survival (PFS) in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac in Phase 2 portion of the study.
12 secondary outcomes
Pharmacokinetics: AUC
Time frame: 18 months
Pharmacokinetics: Cmax
Time frame: 18 months
Pharmacokinetics: Tmax
Time frame: 18 months
Pharmacokinetics: t1/2
Time frame: 18 months
Pharmacodynamic marker assessment
Time frame: 18 months
Anti-drug antibody (ADA) titers
Time frame: 18 months
Objective response rate
Time frame: 18 months
Disease control rate
Time frame: 18 months
Duration of response (DOR)
Time frame: 18 months
Overall survival
Time frame: 30 months
CA-125 response rate
Time frame: 18 months
Quality of Life(QOL)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Franke study director
Aravive, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVB-S6-500, Paclitaxel (Pac) and Pegylated liposomal doxorubicin (PLD) in people with Ovarian Cancer, run by Aravive, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.