Pazopanib Maintenance Phase II
Kata kunci
Abstrak
tanggal
Terakhir Diverifikasi: | 10/31/2017 |
Pertama Dikirim: | 07/30/2014 |
Perkiraan Pendaftaran Telah Dikirim: | 07/30/2014 |
Pertama Diposting: | 08/03/2014 |
Pembaruan Terakhir Dikirim: | 11/07/2017 |
Pembaruan Terakhir Diposting: | 11/12/2017 |
Tanggal Mulai Studi Sebenarnya: | 06/21/2015 |
Perkiraan Tanggal Penyelesaian Utama: | 07/28/2016 |
Perkiraan Tanggal Penyelesaian Studi: | 07/28/2016 |
Kondisi atau penyakit
Intervensi / pengobatan
Drug: Pazopanib
Drug: Placebo
Tahap
Kelompok Lengan
Lengan | Intervensi / pengobatan |
---|---|
Active Comparator: Pazopanib 800mg, oral, 24 months | Drug: Pazopanib |
Placebo Comparator: Placebo 800mg, oral, 24 months | Drug: Placebo |
Kriteria kelayakan
Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
Jenis Kelamin yang Layak untuk Belajar | All |
Menerima Relawan Sehat | Iya |
Kriteria | Inclusion Criteria: - Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up - Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 - 3) according to the FNLCC grading system, tumor size ≥ 5 cm and deep localization with regard to the superficial fascia, excluding the following tumor types: - Embryonal rhabdomyosarcoma - Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma) - Osteosarcoma (excluding extraskeletal osteosarcoma) - Ewing tumors / primitive neuroectodermal tumor (PNET) - Gastro-intestinal stromal tumors (GIST) - Dermatofibrosarcoma protuberans - Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks after surgery - Unstained slides and ideally tumour blocks must be available for histological central review - Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days but no more than 42 days prior to study entry - No evidence of disease following completion of first-line thermochemotherapy and within ≤ 21 days of study entry - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - No other prior chemotherapy except thermochemotherapy with doxorubicin and ifosfamide - Adequate organ system function Exclusion Criteria: - No prior or concurrent second primary malignant tumors (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma) - No symptomatic or known Central nervous system (CNS) metastases at baseline - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: - Active peptic ulcer disease - Known intraluminal metastatic lesion/s with risk of bleeding - Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation - History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment. - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: - Malabsorption syndrome - Major resection of the stomach or small bowel. - Corrected QT interval (QTc) > 480 msecs - History of any one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (See Appendix D for description) - Poorly controlled hypertension (SBP of ≤ 150 mmHg or DBP of ≤95 mmHg is acceptable provided that BP will be treated and monitored at least weekly. The goal is to attain controlled hypertension within 4 weeks of start of IMP which is defined as grade ≤1 hypertension CTCAE Version 4.0) - NYHA II at Screening for Patients > 65 years - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible - Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery). - Evidence of active bleeding or bleeding diathesis. - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage Note: Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions). - Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed. - Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed. - Recent hemoptysis (≥½ teaspoon of red blood within 8 weeks before first dose of study drug). - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. - Treatment with any of the following anti-cancer therapies: - radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR - chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib - Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment - Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia |
Hasil
Ukuran Hasil Utama
1. Progression-free Survival (PFS) [after 58 events have occurred, at the latest 27 month after the final patient is recruited]
Ukuran Hasil Sekunder
1. Overall Survival (OS) [after 58 events have occurred, at the latest 27 month after the final patient is recruited]