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

NCT01574716 | Completed Phase 2 Results

• 2 other identifiers: MORAb-004-203-STS2012-001399-12
• Study Type: interventional
• Target: 209
• Locations: 6 countries
• Sites: 29

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

Outcome Measures

Primary Outcomes (1)

• Part 2: Radiologic Progression-free Survival (PFS)

  PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.

  From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)

Secondary Outcomes (5)

• Part 2: Symptomatic Progression-free Survival

  From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)

• Part 2: Overall Survival (OS)

  From date of first dose until date of death from any cause (up to approximately 3.5 years)

• Part 2: Overall Response Rate (ORR)

  From date of first dose until disease progression (up to approximately 3.5 years)

• Part 2: Radiologic Progression-free Survival Rate (PFR)

  Weeks 12, 24, 48 and 52

• Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels

  Up to approximately 3 years

Study Arms (2)

MORAb-004, gemcitabine, docetaxel

EXPERIMENTAL

Drug: MORAb-004; Drug: Gemcitabine; Drug: Docetaxel

Placebo, gemcitabine, docetaxel

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: Docetaxel; Drug: Placebo

Interventions

MORAb-004 DRUG

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

MORAb-004, gemcitabine, docetaxel

Gemcitabine DRUG

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

MORAb-004, gemcitabine, docetaxel

Docetaxel DRUG

IV, Day 8 of every cycle until disease progression

MORAb-004, gemcitabine, docetaxel

Placebo DRUG

Placebo, gemcitabine, docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphotek: lead

Study Sites (29)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

UCLA

Santa Monica, California, 90404, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101, United States

Location

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, 21231, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 2215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Mayo Clinic - Rochester

Rochester, New York, 55905, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

Seattle Care Alliance

Seattle, Washington, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

UZ Leuven Medical Oncology

Leuven, 3000, Belgium

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

University of Claude Bernard

Villeurbanne, 69100, France

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31034598 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

ontuxizumab; Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 10, 2012
• Study Start: August 7, 2012
• Primary Completion: August 11, 2015
• Study Completion: August 2, 2016
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2016-11

Locations

AU (5); US (19); BE (1); FR (2); IT (1); NL (1)