A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy

NCT ID: NCT01859741

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-07
• Study Completion Date: 2017-05-08

Brief Summary

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.

Detailed Description

The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).

Conditions

Stage IV Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OMP-59R5 Combination with Etoposide and Cisplatin

Group Type: EXPERIMENTAL

OMP-59R5

Intervention Type: DRUG

OMP-59R5 administered intravenously

Etoposide

Intervention Type: DRUG

administered intravenously

Placebo

Intervention Type: DRUG

administered IV

Cisplatin or Carboplatin

Intervention Type: DRUG

administered intravenously

Etoposide and Cisplatin plus Placebo

Group Type: EXPERIMENTAL

OMP-59R5

Intervention Type: DRUG

OMP-59R5 administered intravenously

Etoposide

Intervention Type: DRUG

administered intravenously

Placebo

Intervention Type: DRUG

administered IV

Cisplatin or Carboplatin

Intervention Type: DRUG

administered intravenously

Interventions

OMP-59R5

OMP-59R5 administered intravenously

Intervention Type: DRUG

Etoposide

administered intravenously

Intervention Type: DRUG

Placebo

administered IV

Intervention Type: DRUG

Cisplatin or Carboplatin

administered intravenously

Intervention Type: DRUG

Other Intervention Names

Tarextumab

Eligibility Criteria

Inclusion Criteria

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

1. Histologically or cytologically documented extensive stage small cell lung cancer.

2. Adults of 18 years of age or older.

3. Performance Status (ECOG) of 0 or 1.

4. Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.

5. Adequate organ function:

1. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL).

2. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula).

3. Adequate hepatic function (alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin >1.5 times the upper limit of normal (ULN) unless it is approved by the Sponsor's Medical Monitor).

4. Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN.

6. Written consent on an Institutional Review Board (IRB)/IndependentEthics Committee (IEC)-approved Informed Consent Form prior to any study-specific evaluation.

7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.

8. Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.

Exclusion Criteria

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

1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.

2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer.

3. Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement.

4. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug.

5. A history of malignancy with the exception of:

1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer

2. Adequately treated stage I cancer from which the subject is currently in remission, or

3. Any other cancer from which the subject has been disease-free for ≥ 3 years

6. Known human immunodeficiency virus (HIV) infection.

7. Females who are pregnant or breastfeeding.

8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoMed Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Highlands Oncology Group

Rogers, Arkansas, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Sarah Cannon

Fort Myers, Florida, United States

Ocala Oncology Center, PL

Ocala, Florida, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Georgia Cancer Specialists, PC

Atlanta, Georgia, United States

Univeristy of Chicago Medical Center

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Weinberg Cancer Institute

Baltimore, Maryland, United States

University of Michigan Medical Center, Clinical Trials Office

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Minnesota Oncology Hematology , P.A.

Minneapolis, Minnesota, United States

Oncology Hematology West PC, dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Providence Cancer Center Oncology and Hematology Care Eastside

Portland, Oregon, United States

UPMC Cancer Pavilion

Pittsburgh, Pennsylvania, United States

Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research

Greenville, South Carolina, United States

Tennessee Oncology, PLLC

Chattanooga, Tennessee, United States

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology-South Austin

Austin, Texas, United States

Texas Oncology-Bedford

Bedford, Texas, United States

Texas Oncology, P.A.

Dallas, Texas, United States

The University of Texas MD A nderson Cancer Center

Houston, Texas, United States

Cancer Care Network of South Texas

San Antonio, Texas, United States

Oncology and Hematology Associates of Southwest Virginia Inc.

Blacksburg, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

59R5-003

Identifier Type: -

Identifier Source: org_study_id