Trial of Dasatinib in Advanced Sarcomas

NCT00464620 | Completed Phase 2 Results DMC

• 1 other identifier: SARC009
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 20

Brief Summary

This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.

Conditions

Rhabdomyosarcoma; Malignant Peripheral Nerve Sheath Tumors; Chondrosarcoma; Sarcoma, Ewing's; Sarcoma, Alveolar Soft Part; Chordoma; Epithelioid Sarcoma; Giant Cell Tumor of Bone; Hemangiopericytoma; Gastrointestinal Stromal Tumor (GIST)

Keywords

Dasatinib; Rhabdomyosarcoma; Malignant peripheral nerve sheath tumor; Chondrosarcoma; Ewing's; Alveolar soft part sarcoma (ASPS); Chordoma; Epithelioid sarcoma; Giant cell tumor of bone; Hemangiopericytoma/solitary fibrous tumor; Gastrointestinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (3)

• Response Rate: Number of Participants With Objective Tumor Response

  Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.

  Up to 24 months

• 6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib

  Estimate the 6 month progression-free survival rate of "indolent" sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.

  At 6 months

• 6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)

  To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.

  6 months

Secondary Outcomes (10)

• Median Time-to-progression of Subjects With GIST Treated With Dasatinib.

  Up to 30 months

• Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.

  At 2 and 5 years

• Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.

  Up to 24 months

• 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.

  At 6 months

• Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.

  Up to 37 weeks

Study Arms (1)

Dasatinib, 70 mg, twice daily

EXPERIMENTAL

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Drug: Dasatinib

Interventions

Dasatinib DRUG

oral agent, continuous dosing, Cycles = 28 days

Dasatinib, 70 mg, twice daily

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable, recurrent, or metastatic histologically-confirmed soft tissue or bone sarcoma of one of the following subtypes:
• Leiomyosarcoma --\* NO LONGER ELIGIBLE\*
• Liposarcoma--\* NO LONGER ELIGIBLE\*
• Malignant fibrous histiocytoma (MFH)/pleomorphic undifferentiated sarcoma--\* NO LONGER ELIGIBLE\*
• Rhabdomyosarcoma --\* NO LONGER ELIGIBLE\*
• Malignant peripheral nerve sheath tumor (MPNST) --\* NO LONGER ELIGIBLE\*
• Osteosarcoma (skeletal or extraosseous)--\* NO LONGER ELIGIBLE\*
• Ewing's --\* NO LONGER ELIGIBLE\*
• Chondrosarcoma
• Alveolar soft part sarcoma
• Chordoma
• Epithelioid sarcoma
• Giant cell tumor of bone
• Hemangiopericytoma/solitary fibrous tumor
• Gastrointestinal Stromal Tumor (GIST) --\* NO LONGER ELIGIBLE\*

You may not qualify if:

• Subjects who are curable by conventional multidisciplinary management.
• Subjects with symptomatic central nervous system metastasis.
• Women who are pregnant or nursing/breastfeeding.
• History of significant bleeding disorder unrelated to cancer, including:
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• Subjects currently taking medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) because of a potential increased risk of bleeding from dasatinib.
• Subjects currently taking anticoagulants (warfarin, heparin/low molecular weight heparin \[e.g., danaparoid, dalteparin, tinzaparin, enoxaparin\]) because of a potential increased risk of bleeding from dasatinib.
• Diagnosis of unstable angina or myocardial infarction within 6 months of study entry.
• Subjects currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:
• Quinidine, procainamide, disopyramide
• Amiodarone, sotalol, ibutilide, dofetilide
• Erythromycins, clarithromycin
• Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
• Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead
• Bristol-Myers Squibb: collaborator

Study Sites (20)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30308, United States

Location

Kootenai Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Oncology Specialists

Park Ridge, Illinois, 60068, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• SARC Website

MeSH Terms

Conditions

Rhabdomyosarcoma; Neurofibrosarcoma; Chondrosarcoma; Sarcoma, Ewing; Sarcoma, Alveolar Soft Part; Chordoma; Sarcoma; Giant Cell Tumor of Bone; Hemangiopericytoma; Gastrointestinal Stromal Tumors; Solitary Fibrous Tumors

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Germ Cell and Embryonal; Giant Cell Tumors; Neoplasms, Vascular Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: SARC
• Organization: SARC

sarc@sarctrials.org

(734) 930-7600

Study Officials

• Scott Schuetze, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-10

Locations

US (20)