NCT03030287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2016

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

January 13, 2017

Last Update Submit

September 2, 2020

Conditions

Cancer OvariesCancer PeritonealCancer, Fallopian Tube

Outcome Measures

Primary Outcomes (1)

  • Incidence of dose limiting toxicities (DLT)

    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 Outcomes (5)

  • 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.

    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

    Through study completion, an average of 6 months

  • Response Rate assessed by RECIST criteria 1.1

    At 56 day intervals while on treatment, through study completion, an average of 6 months

  • Response Rate assessed by CA-125 criteria

    At 28 day intervals while on treatment, through study completion, an average of 6 months

  • Progression Free Survival

    Up to 5 years

Study Arms (1)

OMP-305B83 plus paclitaxel

EXPERIMENTAL
Drug: OMP-305B83Drug: Paclitaxel

Interventions

OMP-305B83DRUG

intravenous (in the vein) infusion

Also known as: bispecific monoclonal antibody
OMP-305B83 plus paclitaxel
PaclitaxelDRUG

administered intravenously

OMP-305B83 plus paclitaxel

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
  • Measureable disease per response evaluation criteria (RECIST) v1.1
  • Prior bevacizumab
  • Age \> or = 21 years
  • Adequate organ and marrow function
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • 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.
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
  • Subjects with brain metastases
  • Subjects with leptomeningial disease or neoplasms in the last 5 years
  • Blood pressure \>140/80
  • Significant intercurrent illness that will limit the patient's ability to participate in the study
  • Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
  • 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
  • Pregnant or nursing women
  • New York Heart Association Classification II, III, or IV
  • Inability to comply with study and follow up procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)

Tampa, Florida, 33612, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

The University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Fu S, Corr BR, Culm-Merdek K, Mockbee C, Youssoufian H, Stagg R, Naumann RW, Wenham RM, Rosengarten RD, Benjamin L, Hamilton EP, Moore KN. Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. J Clin Oncol. 2022 Aug 10;40(23):2568-2577. doi: 10.1200/JCO.21.01801. Epub 2022 Apr 19.

    PMID: 35439029DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

navicixizumabAntibodies, BispecificPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 25, 2017

Study Start

December 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

US(7)