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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030287
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Ovaries Cancer Peritoneal Cancer, Fallopian Tube Drug: OMP-305B83 Drug: Paclitaxel Phase 1

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)..

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Start Date : December 2016
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: OMP-305B83 plus paclitaxel Drug: OMP-305B83
intravenous (in the vein) infusion
Other Name: bispecific monoclonal antibody

Drug: Paclitaxel
administered intravenously




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Response Rate assessed by CA-125 criteria [ Time Frame: At 28 day intervals while on treatment, through study completion, an average of 6 months ]
  5. Progression Free Survival [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030287


Locations
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United States, Colorado
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)
Tampa, Florida, United States, 33612
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
The University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03030287    
Other Study ID Numbers: B83-002
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Paclitaxel
Antibodies, Bispecific
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs