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A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02482441
First received: June 19, 2015
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.

Condition Intervention Phase
Advanced Relapsed Tumors Refractory Solid Tumors Drug: OMP-131R10 Drug: FOLFIRI Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 in Advanced Solid Tumors and in Combination With FOLFIRI for Patients With Previously Treated Metastatic Colorectal Cancer

Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: DLTs during the evaluation (28 days) ]
    Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.


Estimated Enrollment: 50
Study Start Date: June 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMP-131R10 intravenous (in the vein) infusions
OMP-131R10 will be administered IV on the first day of each 14-day cycle.
Drug: OMP-131R10
There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
Other Name: OMP-131R10, IgG1 humanized monoclonal antibody
Drug: FOLFIRI
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
Experimental: FOLFIRI (5-FU, irinotecan, leucovorin).
dosing continues up to the 20 mg/kg dose level
Drug: OMP-131R10
There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
Other Name: OMP-131R10, IgG1 humanized monoclonal antibody
Drug: FOLFIRI
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.

Detailed Description:

The Phase 1a portion of the study in subjects with advanced solid tumors will consist of a dose escalation part followed by a dose-expansion cohort. OMP-131R10 will be administered IV on the first day of each 14-day cycle.

Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.

The Phase 1b portion of the study will be conducted in subjects with metastatic colorectal cancer whose tumors have progressed after at least 1 line of therapy for metastatic disease.

Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for the study:

  1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
  2. Age ≥18 years
  3. ECOG performance status 0 or 1 (see Appendix B)
  4. Must have evaluable disease per RECIST 1.1. (see Appendix C)
  5. Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible).
  6. Must have received their last anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy at least 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, from initiation of study treatment.
  7. Platelets >100,000/mL without transfusions in the past 7 days
  8. Total bilirubin within 1.5x institutional upper limit of normal (ULN)

    • AST (SGOT) and ALT (SGPT) <3 X institutional ULN
    • Patients with documented liver metastases: AST (SGOT) and/or ALT (SGPT) ≤ 5 × ULN
    • Albumin ≥ 3.0 g/dL
    • Creatinine <1.5 X institutional ULN OR
    • Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal

Exclusion Criteria:

Subjects who meet any of the following criteria will not be eligible for participation in the study:

  1. Currently receiving any therapeutic treatment for their malignancy including other investigational agents
  2. Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously treated CNS metastases, are asymptomatic, and have no requirement for a corticosteroid dose (indicated to reduce brain edema) that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
  3. History of a Grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
  4. Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  5. Pregnant women or nursing women
  6. Subjects with congestive heart failure with New York Heart Association Classification III, or IV (see Appendix D)
  7. Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02482441

Contacts
Contact: Leonardo Faoro, MD 650-650-3632 leonardo.faoro@oncomed.com

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 95115
Contact: Brittany Bianchi    415-885-3725    brittany.bianchi@ucsf.edu   
Contact: Ilaria Mastroserio    415-514-6245    ilaria.mastroserio@ucsf.edu   
Principal Investigator: Pamela Munster, MD         
United States, Colorado
University of Colorado Hospital Anschulz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Gail Eckhardt, MD    303-724-3850    gail.eckhardt@ucdenver.edu   
Principal Investigator: Gail Eckhardt, MD         
United States, Connecticut
Yale Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Kamil Sadowski    203-785-6661    kamil.sadowski@yale.edu   
Principal Investigator: Howard Hochster, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: John Strickler, MD         
Contact: Tony Amara    919-668-1861    anthony.amara@duke.edu   
United States, Tennessee
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Chock Bendell, MD    615-320-5090    jbendell@tnonc.com   
Principal Investigator: Johanna Chock Bendell, MD         
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Van Morris, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02482441     History of Changes
Other Study ID Numbers: 131R10-001
Study First Received: June 19, 2015
Last Updated: March 3, 2017

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Advanced Solid Tumors and in Combination
FOLFIRI for Patients with Previously Treated Metastatic
Colorectal Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 26, 2017