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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. )

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date September 3, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • Response Rate assessed by CA-125 criteria [ Time Frame: At 28 day intervals while on treatment, through study completion, an average of 6 months ]
  • Progression Free Survival [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer
Official Title  ICMJE A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer Ovaries
  • Cancer Peritoneal
  • Cancer, Fallopian Tube
Intervention  ICMJE
  • Drug: OMP-305B83
    intravenous (in the vein) infusion
    Other Name: bispecific monoclonal antibody
  • Drug: Paclitaxel
    administered intravenously
Study Arms  ICMJE Experimental: OMP-305B83 plus paclitaxel
Interventions:
  • Drug: OMP-305B83
  • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2020)
44
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2017)
30
Actual Study Completion Date  ICMJE April 2020
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030287
Other Study ID Numbers  ICMJE B83-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )
Study Sponsor  ICMJE OncoMed Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mereo BioPharma
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP