A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer

September 2, 2020 updated by: OncoMed Pharmaceuticals, Inc.

A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Medical Campus
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The University of Pennsylvania Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas, MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
  2. Measureable disease per response evaluation criteria (RECIST) v1.1
  3. Prior bevacizumab
  4. Age > or = 21 years
  5. Adequate organ and marrow function
  6. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
  7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
  2. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
  3. Subjects with brain metastases
  4. Subjects with leptomeningial disease or neoplasms in the last 5 years
  5. Blood pressure >140/80
  6. Significant intercurrent illness that will limit the patient's ability to participate in the study
  7. Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
  8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
  9. Pregnant or nursing women
  10. New York Heart Association Classification II, III, or IV
  11. Inability to comply with study and follow up procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMP-305B83 plus paclitaxel
Drug: Paclitaxel
administered intravenously
Drug: OMP-305B83
intravenous (in the vein) infusion
Other Names:
  • bispecific monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicities (DLT)
Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Up to 5 years
Up to 5 years
Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Response Rate assessed by RECIST criteria 1.1
Time Frame: At 56 day intervals while on treatment, through study completion, an average of 6 months
At 56 day intervals while on treatment, through study completion, an average of 6 months
Response Rate assessed by CA-125 criteria
Time Frame: At 28 day intervals while on treatment, through study completion, an average of 6 months
At 28 day intervals while on treatment, through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OncoMed Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B83-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer Ovaries

Clinical Trials on Paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe