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

NCT03639246 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AVB500-OC-002
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 16

Brief 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. 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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; Platinum resistant

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (AEs)

  Measured by the number of patients with AEs in Phase 1 portion of the study.

  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.

  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.

  18 months

Secondary Outcomes (12)

• Pharmacokinetics: AUC

  18 months

• Pharmacokinetics: Cmax

  18 months

• Pharmacokinetics: Tmax

  18 months

• Pharmacokinetics: t1/2

  18 months

• Pharmacodynamic marker assessment

  18 months

Study Arms (6)

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

Interventions

AVB-S6-500 DRUG

AVB-S6-500 is experimental 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) DRUG

Paclitaxel is active comparator

Also known as: Taxol

Phase 1b: AVB-S6-500+Pac; Phase 2: AVB-S6-500+Pac; Phase 2: Placebo+Pac

Pegylated liposomal doxorubicin (PLD) DRUG

PLD is active comparator

Also known as: Doxil

Phase 1b: AVB-S6-500+PLD; Phase 2: AVB-S6-500+PLD; Phase 2: Placebo+PLD

Placebo OTHER

Placebo comparator

Phase 2: Placebo+PLD; Phase 2: Placebo+Pac

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aravive, Inc.: lead

Study Sites (16)

Arizona Oncology

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

Location

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente Walnut Creek

Walnut Creek, California, 94596, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

OUHSC-Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology - Austin Central

Austin, Texas, 78731, United States

Location

Texas Oncology - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; Chromosomes, Artificial, P1 Bacteriophage; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chromosomes, Artificial; Chromosomes; Genetic Structures; Genetic Phenomena; Genetic Vectors

Study Officials

• Amy Franke

  Aravive, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: December 6, 2018
• Primary Completion: January 8, 2021
• Study Completion: December 30, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)