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A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OMP-305B83
FOLFIRI
FOLFOX
Sponsored by
OncoMed Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
  • Age >21 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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

Exclusion Criteria:

  • Receiving any other investigational agents or any other anti-cancer therapy
  • Receiving prior hepatic intra-arterial chemotherapy
  • Known significant clinically significant gastrointestinal disease
  • Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
  • Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
  • Pregnant or nursing women
  • Inability to comply with study and follow up procedure

Sites / Locations

  • City of Hope National Medical Center
  • Rocky Mountain Cancer Centers
  • Cancer Care & Hematology - Fort Collins
  • University of Michigan Health System
  • Washington University School of Medicine Siteman Cancer Center
  • University of Utah, Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMP-305B83 combined with FOLFIRI or FOLFOX

Arm Description

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX

Secondary Outcome Measures

Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX 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.
Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX
Response Rate assessed by RECIST criteria 1.1
Response Rate assessed by tumor marker CEA
Progression Free Survival

Full Information

First Posted
December 22, 2016
Last Updated
August 10, 2020
Sponsor
OncoMed Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03035253
Brief Title
A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer
Official Title
A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoMed Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific 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. The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
Detailed Description
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal 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 up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMP-305B83 combined with FOLFIRI or FOLFOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OMP-305B83
Other Intervention Name(s)
bispecific monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities
Description
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
Time Frame
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
Secondary Outcome Measure Information:
Title
Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX 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 8 months
Title
Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX
Time Frame
Through study completion, an average of 8 months
Title
Response Rate assessed by RECIST criteria 1.1
Time Frame
At 56 day intervals while on treatment, through study completion, an average of 8 months
Title
Response Rate assessed by tumor marker CEA
Time Frame
At 28 day intervals while on treatment, through study completion, an average of 8 months
Title
Progression Free Survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1 Age >21 years Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 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 Exclusion Criteria: Receiving any other investigational agents or any other anti-cancer therapy Receiving prior hepatic intra-arterial chemotherapy Known significant clinically significant gastrointestinal disease Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months Pregnant or nursing women Inability to comply with study and follow up procedure
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Cancer Care & Hematology - Fort Collins
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2800
Country
United States
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer

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