Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

NCT ID: NCT01574716

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-07
• Study Completion Date: 2016-08-02

Brief Summary

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

Conditions

Metastatic Soft Tissue Sarcoma

Study Design

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

Study Groups

MORAb-004, gemcitabine, docetaxel

Group Type: EXPERIMENTAL

MORAb-004

Intervention Type: DRUG

IV, Days 1 and 8 of every cycle until disease progression

Gemcitabine

Intervention Type: DRUG

IV, Days 1 and 8 of each cycle until disease progression

Docetaxel

Intervention Type: DRUG

IV, Day 8 of every cycle until disease progression

Placebo, gemcitabine, docetaxel

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

IV, Days 1 and 8 of each cycle until disease progression

Docetaxel

Intervention Type: DRUG

IV, Day 8 of every cycle until disease progression

Placebo

Intervention Type: DRUG

Interventions

MORAb-004

IV, Days 1 and 8 of every cycle until disease progression

Intervention Type: DRUG

Gemcitabine

IV, Days 1 and 8 of each cycle until disease progression

Intervention Type: DRUG

Docetaxel

IV, Day 8 of every cycle until disease progression

Intervention Type: DRUG

Gemcitabine

IV, Days 1 and 8 of each cycle until disease progression

Intervention Type: DRUG

Docetaxel

IV, Day 8 of every cycle until disease progression

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be at least 18 years of age
• Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
• Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
• Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
• Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
• Have tumor tissue available for TEM-1 biomarker studies
• Be willing and able to provide written informed consent

Exclusion Criteria

• Have received more than 2 prior systemic treatment regimens for mSTS
• Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
• Have a diagnosis of primary bone sarcoma of any histological type.
• Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
• Have a history of allergic reaction to prior monoclonal antibody or biologic agent
• Have received previous treatment with MORAb-004 (anti-TEM-1)
• Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
• Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
• Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture

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

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sarcoma Oncology Center

Santa Monica, California, United States

UCLA

Santa Monica, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Washington University

St Louis, Missouri, United States

Mount Sinai Medical Center

New York, New York, United States

Mayo Clinic - Rochester

Rochester, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Seattle Care Alliance

Seattle, Washington, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

UZ Leuven Medical Oncology

Leuven, , Belgium

Institut Gustave Roussy

Villejuif, , France

University of Claude Bernard

Villeurbanne, , France

Istituto Ortopedico Rizzoli

Bologna, , Italy

Leiden University Medical Center

Leiden, , Netherlands

Countries

United States; Australia; Belgium; France; Italy; Netherlands

References

Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.

Reference Type: DERIVED

PMID: 31034598 (View on PubMed)

Other Identifiers

2012-001399-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MORAb-004-203-STS

Identifier Type: -

Identifier Source: org_study_id