Pazopanib Maintenance Phase II

NCT ID: NCT02207309

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-22
• Study Completion Date: 2016-07-29

Brief Summary

This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.

Conditions

Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pazopanib

800mg, oral, 24 months

Group Type: ACTIVE_COMPARATOR

Pazopanib

Intervention Type: DRUG

Placebo

800mg, oral, 24 months

Group Type: PLACEBO_COMPARATOR

Placebo (for Pazopanib)

Intervention Type: DRUG

Interventions

Pazopanib

Intervention Type: DRUG

Placebo (for Pazopanib)

Intervention Type: DRUG

Other Intervention Names

Votrient

Eligibility Criteria

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

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

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Lars Lindner

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Lindner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Ludwig-Maximilians University of Munich, Klinikum Großhadern

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

2013-000522-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NPM001

Identifier Type: -

Identifier Source: org_study_id