Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

NCT00568750 | Completed Phase 2

• 5 other identifiers: SAKK 56/07SWS-SAKK-56/07EU-20789EUDRACT-2007-002047-24CDR0000577496
• Study Type: interventional
• Target: 47
• Locations: 4 countries
• Sites: 18

Brief Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor

Outcome Measures

Primary Outcomes (1)

• Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria

  at 4 weeks compared to baseline

Secondary Outcomes (8)

• Best response as assessed by CT scan/MRI

  according to RECIST criteria

• Best response as assessed by fusion PET/CT scan

  at 4 weeks

• Clinical benefit

  Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST

• Time to progression

  calculated from registration until progression or death due to tumor

• Progression-free survival

  calculated from registration until progression or death

Study Arms (1)

Dasatinib

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).

Also known as: Sprycel

Dasatinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed gastrointestinal stromal tumor (GIST) * Measurable disease by conventional scans (CT scan or MRI) within 2 weeks prior to study registration * Positive PET/CT scan with \[\^18F\]-fluorodeoxyglucose uptake of the target lesions within 2 weeks prior to study registration * No signs or history of CNS metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Hemoglobin ≥ 90 g/L (transfusion allowed) * Neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Bilirubin ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * AST and/or ALT ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study therapy * No other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No hypocalcemia (i.e., serum calcium ≤ lower limit of normal) * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension * Congestive heart failure within the past 6 months * QTc \> 450 msec or major conduction abnormality (unless a cardiac pacemaker is present) * No concurrent medical condition (e.g., active autoimmune disease or uncontrolled diabetes) that would impair the ability of the patient to participate in the study (at the judgment of the investigator) or that may increase the risk of toxicity, including any of the following: * Pleural or pericardial effusion of any grade * Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease) * Infection requiring intravenous antibiotics * Ongoing significant gastrointestinal bleeding * Nausea, vomiting, or malabsorption syndrome that could interfere with ingestion or absorption of oral dasatinib * No known hypersensitivity to study drug PRIOR CONCURRENT THERAPY: * No prior therapy for GIST, particularly tyrosine kinase inhibitors at any time * More than 30 days since prior participation in a clinical trial * At least 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following: * Itraconazole, ketoconazole, miconazole, and voriconazole * Amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, and ritonavir * Ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, imatinib mesylate, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, and telithromycin * At least 7 days since prior and no concurrent medications known to prolong the QT interval, including any of the following: * Quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, and dofetilide * Erythromycin and clarithromycin * Chlorpromazine, haloperidol, mesoridazine, thioridazine, and pimozide * Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine * No concurrent IV bisphosphonates during the first 8 weeks of study treatment * No other concurrent experimental drugs or anticancer therapy * No concurrent drugs contraindicated for use with dasatinib, according to the dasatinib investigator's brochure

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (18)

Biomedicum Helsinki

Helsinki, FI-00290, Finland

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Montemurro, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

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: December 5, 2007
• First Posted: December 6, 2007
• Study Start: January 22, 2008
• Primary Completion: January 18, 2012
• Study Completion: May 16, 2018
• Last Updated: June 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (12); FI (1); FR (4); DE (1)